217 Quality Lead jobs in Malaysia

Job responsibilities:

Responsible for the operational aspects of all analytical testing within the QC Laboratory.

• Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
• Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
• Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
• Develop the organisation's quality testing policy in alignment with regulatory standards.
• Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
• Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
• Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
• Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
• Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
• Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
• Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.
• Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech transfer purposes.
• Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.

Qualifications:

• PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience, or Master/Bachelor’s degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.
• Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.
• Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
• Experience in the design and optimization of cell-based potency and infectivity assays.
• Must have experience facing regulatory, Client & external cGMP audits.
• Must have the knowledge of contract testing labs management and its certification.
• Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products.
• Experience with processes involved in viral vector GMP manufacturing, characterization and QC release testing.
• A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.
• Excellent organizational and collaborative skills.

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About the Job:

Position: Quality & Compliance Lead – Pet Food (Independent Contractor)
Work Set-up: Remote Work

Job Summary :

• The Quality & Compliance Lead – Pet Food will be in charge of regulatory compliance processes, ensuring adherence to international and local regulations concerning import, export, product packaging, and food safety.
• The role requires a proactive individual with expertise in quality standards, regulatory requirements, and training development.
• This position will also provide support to Quality Assurance and Sales teams and manage supplier accreditation processes.
• This is a remote position with occasional travel requirements.

Key Responsibilities:

• Manage regulatory compliance tasks, including obtaining import and export permits, reviewing packaging for new products, and reviewing Overseas Market Access Requirements (OMAR).
• Handle all regulatory-related tasks, ensuring the company’s compliance with industry standards and government regulations.
• Manage complaints related to product quality; conduct root cause analysis and implement corrective actions as needed.
• Support the Sales team with regulatory and compliance matters concerning OEM (Original Equipment Manufacturer) operations.
• Oversee supplier accreditation processes and ensure suppliers meet all regulatory requirements.
• Conduct training sessions on Food Safety, HACCP, and other relevant compliance topics.
• Develop and recommend quality and safety programs, including the creation and implementation of Standard Operating Procedures (SOPs).
• Collaborate with and provide support to the Quality Assurance team to uphold product quality and safety standards.
• Stay updated on international regulations and apply relevant insights to enhance compliance processes and systems.

Job Qualifications:

• Bachelor’s degree in Food Science, Chemistry, Regulatory Affairs, or a related field.
• Minimum of 5 years of experience in regulatory compliance, preferably within the food manufacturing or pet food industry.
• Strong understanding of regulatory requirements for import, export, packaging, and food safety.
• Certification in HACCP, Food Safety, or equivalent is an advantage.
• Experience in supplier audits and supplier management.
• Excellent communication and training skills with the ability to develop and deliver compliance training programs.
• Analytical skills to manage complaints and perform quality-related investigations.
• Ability to work independently and collaboratively with cross-functional teams.
• Knowledge of international regulatory frameworks is a plus.

Key Competencies:

• Detail-oriented and well-organized.
• Strong problem-solving and decision-making abilities.
• Ability to handle multiple tasks and prioritize effectively.
• Strong interpersonal and leadership skills.

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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Quality & Compliance Lead - Pharma PDQ

Location: Kuala Lumpur

Are you a seasoned Quality & Compliance professional ready to make a significant impact in the pharmaceutical industry? Join our dynamic Pharma PDQ team as a Senior Quality & Compliance Lead and play a pivotal role in ensuring global regulatory compliance and patient protection.

The Opportunity:

This critical position is responsible for leading and managing the identification of medical compliance risks, escalating them to the Chief Medical Officer, and aligning medical compliance efforts across our global Affiliates. You will be the primary point of contact for country medical directors and the Deputy Chief Medical Officer regarding Affiliate Oversight, owning the process, identifying risks, and addressing escalations through the OneRoche & Medical Compliance Governance framework.

Beyond regulatory compliance, you will be instrumental in ensuring inspection readiness and leading major regulatory authority inspections globally, encompassing strategic planning, management, and execution of all inspection-related activities. Your collaborative approach will be essential in working with sites and cross-functional study teams to proactively identify and address potential risks.

Key Responsibilities:

• Medical Compliance: Accountable for affiliate oversight data analysis, acting as an escalation point for country medical directors, and contributing to continuous improvement initiatives.
• Governance & Escalation: Ensure escalations are captured and addressed through appropriate case management and enable the escalation of Affiliate topics through the OneRoche Medical Governance process.
• Risk Management: Implement the Risk Management Process for Affiliates' priority countries, identify and monitor cross-affiliate trends, and support risk mitigation strategies.
• Medical Compliance & Strategy Integration: Act as a catalyst to embed medical compliance strategy at Affiliates, fostering knowledge, skills, and mindset within the OneRoche Governance & Medical Compliance ecosystem.
• Networking: Partner with various internal and external groups, build strong relationships with the country's medical director community, and provide comprehensive compliance assessments.
• Inspections: Manage all aspects of inspection readiness, represent the organization during major health authority inspections (e.g., FDA, EMA, PMDA, MFDS), and lead mock inspections.

Qualifications & Experience:

• Master's, Bachelor’s degree, or equivalent in a scientific or quality-related field, or equivalent combination of education, training, and experience.
• Demonstrated applied knowledge of global regulatory requirements in the pharmaceutical industry, particularly in clinical (GCP), pharmacovigilance (GVP), device, or Quality.
• Expert knowledge of FDA, EU, and ICH GCP guidelines and regulatory compliance.
• Fluency in written and spoken English and Mandarin, bilingual or multilingual skills are required.
• Proven ability to manage multiple priorities in a dynamic, fast-paced environment and lead complex inspection activities.

Skills and Competencies:

• Strong digital and data literacy, proficiency, Google suite.
• Advanced communication and presentation skills.
• Proven ability to manage multiple priorities in a dynamic, fast-paced environment and lead complex inspection activities.
• Ability to influence, negotiate, and work effectively in an international, multicultural matrix organization.
• Strong critical thinking, analytical, problem-solving, and decision-making skills.
• Strong interpersonal skills, leadership experience in global project teams, and excellent project management skills.
• Strategic insights analysis, high learning agility, proactive risk-based approach, and an enterprise-wide mindset.

If you are a proactive leader with a strong understanding of quality and compliance within the pharmaceutical development landscape, we encourage you to apply and contribute to our mission of accelerating the delivery of medicines to patients.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

#J-18808-Ljbffr

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Quality & Compliance Lead - Pharma PDQ

Location: Kuala Lumpur

Are you a seasoned Quality & Compliance professional ready to make a significant impact in the pharmaceutical industry? Join our dynamic Pharma PDQ team as a Senior Quality & Compliance Lead and play a pivotal role in ensuring global regulatory compliance and patient protection.

The Opportunity:

This critical position is responsible for leading and managing the identification of medical compliance risks, escalating them to the Chief Medical Officer, and aligning medical compliance efforts across our global Affiliates. You will be the primary point of contact for country medical directors and the Deputy Chief Medical Officer regarding Affiliate Oversight, owning the process, identifying risks, and addressing escalations through the OneRoche & Medical Compliance Governance framework.

Beyond regulatory compliance, you will be instrumental in ensuring inspection readiness and leading major regulatory authority inspections globally, encompassing strategic planning, management, and execution of all inspection-related activities. Your collaborative approach will be essential in working with sites and cross-functional study teams to proactively identify and address potential risks.

Key Responsibilities:

• Medical Compliance: Accountable for affiliate oversight data analysis, acting as an escalation point for country medical directors, and contributing to continuous improvement initiatives.
• Governance & Escalation: Ensure escalations are captured and addressed through appropriate case management and enable the escalation of Affiliate topics through the OneRoche Medical Governance process.
• Risk Management: Implement the Risk Management Process for Affiliates' priority countries, identify and monitor cross-affiliate trends, and support risk mitigation strategies.
• Medical Compliance & Strategy Integration: Act as a catalyst to embed medical compliance strategy at Affiliates, fostering knowledge, skills, and mindset within the OneRoche Governance & Medical Compliance ecosystem.
• Networking: Partner with various internal and external groups, build strong relationships with the country's medical director community, and provide comprehensive compliance assessments.
• Inspections: Manage all aspects of inspection readiness, represent the organization during major health authority inspections (e.g., FDA, EMA, PMDA, MFDS), and lead mock inspections.

Qualifications & Experience:

• Master's, Bachelor’s degree, or equivalent in a scientific or quality-related field, or equivalent combination of education, training, and experience.
• Demonstrated applied knowledge of global regulatory requirements in the pharmaceutical industry, particularly in clinical (GCP), pharmacovigilance (GVP), device, or Quality.
• Expert knowledge of FDA, EU, and ICH GCP guidelines and regulatory compliance.
• Fluency in written and spoken English and Mandarin, bilingual or multilingual skills are required.
• Proven ability to manage multiple priorities in a dynamic, fast-paced environment and lead complex inspection activities.

Skills and Competencies:

• Strong digital and data literacy, proficiency, Google suite.
• Advanced communication and presentation skills.
• Proven ability to manage multiple priorities in a dynamic, fast-paced environment and lead complex inspection activities.
• Ability to influence, negotiate, and work effectively in an international, multicultural matrix organization.
• Strong critical thinking, analytical, problem-solving, and decision-making skills.
• Strong interpersonal skills, leadership experience in global project teams, and excellent project management skills.
• Strategic insights analysis, high learning agility, proactive risk-based approach, and an enterprise-wide mindset.

If you are a proactive leader with a strong understanding of quality and compliance within the pharmaceutical development landscape, we encourage you to apply and contribute to our mission of accelerating the delivery of medicines to patients.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

#J-18808-Ljbffr

Brief Job Description:

Responsible for ensuring that the products and services meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to. Responsible for identifying and raising quality issues and for speedily resolving them to ensure zero impact to the customer. Support comprehensive quality management system build up to ensure the robustness of product builds and service offers. Work in a team environment to develop and implement best practices that emphasise defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements. Able to prepare and present quality assurance reports, familiar with various quality techniques and methodologies

Responsibilities and Measurement Criteria with Time investment Needed on Each:

(This will describe the overall core responsibilities of the role, decision making responsibilities etc.)

• Manufacturing and Product Quality
• Analyze product test data, manufacturing measures and field performance to improve product quality
• Work with factory / outsourced partner and cross functional team in resolution of key quality issues
• Initiate and drive continuous quality improvement of processes within respective areas, and support Vertiv Operating System (VOS) rollout with the ability to measure progress with data
• Lesson Learnt / Best practice sharing across region
• Deploy, train and audit quality policies, standards, and procedures for respective manufacturing locations, sub-contracting (3rd party), and service activities. Collaborate on improvement initiatives leading to high quality level products
• Service Quality
• Work with Regional Service Teams to establish the foundation and quality management system for Service Quality
• Perform internal audit, coordinate quality management reviews, and drive continual improvement
• Maintain documents of the Quality Management System
• Customer Quality
• Customer Claims management coordination
• Coordinate customer audits, and manage improvement actions
• Conduct contract reviews for customer contract documentation
• Supplier Quality (in cooperation with Market Unit, Supplier Quality organization and Supply Chain)
• Support the Regional and Global Supplier Quality Teams, and Supply Chain organization by providing strategic quality support and expertise for supplier quality programs
• Metric Reporting
• Provide monthly reporting for relevant Quality KPI (E.g.: Warranty, Field Failure Rate, etc.), supported with detail analysis and improvement action plan
• Others
• Develop and maintain effective communication within the business
• Perform other duties and oversee special projects and assignments as may be assigned by management

Qualifications:

Required/ Minimum Qualifications:

• BE – Electronics/Electrical / Mechanical or related field
• Minimum 5 – 8 years of experience in Quality Management and in Mechanical ElectricalElectronics Manufacturing Industry. Experience with Data centre industry will be an added advantage
• Strong leadership skills
• Fluent in English and Mandarin
• Excellent communication – interpersonal and customer relationship skills
• IT skills—MS Excel (Intermediate to advanced) / MS office/ PowerBI /Smartsheet
• Problem-solving skills – Excellent problem solver, good knowledge of 8D methodology / Quality tools, an understanding of statistics (Analytical /numerical skills)
• CQE, CRE, Six Sigma and Lean certification will be an added advantage
• Self-starter; Ability to work independently with minimum supervision; Ability to work under pressure and manage multiple and conflict priorities;
• Computer literate, specifically the MS Office package (Access included).
• Ability to plan activities in short midterm.
• Ability to coordinate people from different departments.
• Highly customer focused.
• Attitude to listen customers' (internal and external) needs.
• Working in team.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

Additional / Preferred Qualifications:

Physical & Environmental Requirements: - (To be used majorly for manufacturing jobs.)

• None

Time Travel Needed:

• ~15%

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Brief Job Description: Responsible for ensuring that the products and services meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to. Responsible for identifying and raising quality issues and for speedily resolving them to ensure zero impact to the customer. Support comprehensive quality management system build up to ensure the robustness of product builds and service offers. Work in a team environment to develop and implement best practices that emphasise defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements. Able to prepare and present quality assurance reports, familiar with various quality techniques and methodologies Responsibilities and Measurement Criteria with Time investment Needed on Each: (This will describe the overall core responsibilities of the role, decision making responsibilities etc.) Manufacturing and Product Quality Analyze product test data, manufacturing measures and field performance to improve product quality Work with factory / outsourced partner and cross functional team in resolution of key quality issues Initiate and drive continuous quality improvement of processes within respective areas, and support Vertiv Operating System (VOS) rollout with the ability to measure progress with data Lesson Learnt / Best practice sharing across region Deploy, train and audit quality policies, standards, and procedures for respective manufacturing locations, sub-contracting (3rd party), and service activities. Collaborate on improvement initiatives leading to high quality level products Service Quality Work with Regional Service Teams to establish the foundation and quality management system for Service Quality Perform internal audit, coordinate quality management reviews, and drive continual improvement Maintain documents of the Quality Management System Customer Quality Customer Claims management coordination Coordinate customer audits, and manage improvement actions Conduct contract reviews for customer contract documentation Supplier Quality (in cooperation with Market Unit, Supplier Quality organization and Supply Chain) Support the Regional and Global Supplier Quality Teams, and Supply Chain organization by providing strategic quality support and expertise for supplier quality programs Metric Reporting Provide monthly reporting for relevant Quality KPI (E.g.: Warranty, Field Failure Rate, etc.), supported with detail analysis and improvement action plan Others Develop and maintain effective communication within the business Perform other duties and oversee special projects and assignments as may be assigned by management Qualifications: Required/ Minimum Qualifications: BE – Electronics/Electrical / Mechanical or related field Minimum 5 – 8 years of experience in Quality Management and in Mechanical ElectricalElectronics Manufacturing Industry. Experience with Data centre industry will be an added advantage Strong leadership skills Fluent in English and Mandarin Excellent communication – interpersonal and customer relationship skills IT skills—MS Excel (Intermediate to advanced) / MS office/ PowerBI /Smartsheet Problem-solving skills – Excellent problem solver, good knowledge of 8D methodology / Quality tools, an understanding of statistics (Analytical /numerical skills) CQE, CRE, Six Sigma and Lean certification will be an added advantage Self-starter; Ability to work independently with minimum supervision; Ability to work under pressure and manage multiple and conflict priorities; Computer literate, specifically the MS Office package (Access included). Ability to plan activities in short midterm. Ability to coordinate people from different departments. Highly customer focused. Attitude to listen customers' (internal and external) needs. Working in team. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Additional / Preferred Qualifications: Physical & Environmental Requirements: - (To be used majorly for manufacturing jobs.) None Time Travel Needed: ~15%

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Description

Position at Samtec, Inc

Job title: MANUFACTURING QUALITY SUPPORT (MQS)

Summary/Objective

The Manufacturing Quality Support role requires a self-motivated, organized, and adaptable individual with strong multitasking abilities. This person will collaborate with the relevant production areas (e.g., Stamping, Molding, Plating, HDR, Optics, Automation, Traffic, and Inventory) to prevent quality issues and improve overall quality performance. Additionally, this role will be responsible for monitoring and improving process performance through internal auditing.

Essential Functions/ Responsibilities.

• Quality Ownership – Take shared responsibility for quality metrics within the assigned production area.
• Cross-Functional Collaboration – Work closely with production supervisors, product, tooling, process, and maintenance techs, as well as Customer Quality Engineers (CQEs) to drive quality prevention and improvement initiatives.
• Data Analysis & Improvement Planning – Track and monitor quality metrics, analyze data trends, and develop action plans for continuous improvement.
• Issue Investigation & Resolution – Collaborate with supervisors, engineers, and CQEs to investigate internal and external defects or reported issues, identify root causes, implement corrective actions, and track progress until resolution.
• Quality Standards Guidance – Provide guidance to operators and supervisors on maintaining quality standards.
• Documentation Updates – Develop, maintain, and/or coordinate the creation of or updates to applicable documentation.
• In-Process Audits (IPA), Inspections, and Floor Walks – Conduct in-process audits per standards and requirements. Perform directed in-process inspections on specific orders, part numbers, or processes as determined by the Quality Department. Verify adherence to product specifications, proper procedures, and data collection requirements for new and existing products (e.g., CQA, ASP, and New Products). Also, lead manufacturing floor walks or Gemba walks.
• Quality Reporting & Communication – Prepare the End-of-Month (EOM) Quality Update following the standard template. Update weekly quality metrics and share Quality Performance (QPs) updates on the Production Communication Board.
• Review Board Administration – Serve as the Review Board Administrator, overseeing the review of incoming QPs and ensuring the completion of tasks and effectiveness of implemented actions.
• Material Containment & Issue Management – Identify and implement containment measures for affected materials when necessary.
• Product Transfers & Approvals – Support product transfer inspections, approvals, and tracking.
• Manufacturing Floor Support – Act as a liaison between Manufacturing and other support groups (Tooling, Engineering, Sales, etc.), as well as different manufacturing areas (Plating, Stamping, Molding, Automation, HDR, etc.).
• Training & Corrective Action Monitoring – Assist in training and monitoring production operators on specific quality concerns. Support documentation and verification of corrective actions.
• Skills Development – take up new responsibilities assigned by manager
• Additional Responsibilities – Occasional off shift coverage (if needed).
  
  

“The responsibilities as defined are intended to serve as a general guideline for this position. Associates may be asked to perform additional tasks depending on strengths and capabilities.”

Required Experience

• Strong data analysis skills; must be data-driven in decision-making and evaluation.
• Solid understanding of process knowledge relevant to the assigned area.
• Excellent problem-solving and investigative skills with a strong attention to detail.
• Effective written and verbal communication skills.
• Proficient in Microsoft Office applications, including Outlook, Excel, Word, and Access.
• Collaborative team player; able to work effectively with operators, floor managers, engineers, and cross-functional teams.
• Must be able to sit/stand for at least 90 consecutive minutes and not suffer from any sensory deprivation and/or paralysis of the limbs.
  
  

Preferred Experience

• Previous experience in quality assurance or related field.
• Familiarity with Samtec quality systems: QP Suite, Checkpoint, Audit Suite, etc.
• Working knowledge of dimensional inspection tools (Micro-Vu, Drop Gage, Calipers, etc.).
  
  

Required Education: High school diploma or equivalent

Preferred Education: College-level education in engineering, or completion of some engineering coursework.

SAMTEC, Inc. is an Equal Opportunity Employer and committed to creating a diverse environment. All employment decisions at Samtec are based in business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, pregnancy or parental status, age, disability, sexual orientation, gender and/or gender identity/expression, marital status, past or present military service, family medical history or genetic information, or any other status protected by applicable laws. #J-18808-Ljbffr

Description Position at Samtec, Inc

Job title: MANUFACTURING QUALITY SUPPORT (MQS) Summary/Objective The Manufacturing Quality Support role requires a self-motivated, organized, and adaptable individual with strong multitasking abilities. This person will collaborate with the relevant production areas (e.g., Stamping, Molding, Plating, HDR, Optics, Automation, Traffic, and Inventory) to prevent quality issues and improve overall quality performance. Additionally, this role will be responsible for monitoring and improving process performance through internal auditing. Essential Functions/ Responsibilities. 1. Quality Ownership – Take shared responsibility for quality metrics within the assigned production area. 2. Cross-Functional Collaboration – Work closely with production supervisors, product, tooling, process, and maintenance techs, as well as Customer Quality Engineers (CQEs) to drive quality prevention and improvement initiatives. 3. Data Analysis & Improvement Planning – Track and monitor quality metrics, analyze data trends, and develop action plans for continuous improvement. 4. Issue Investigation & Resolution – Collaborate with supervisors, engineers, and CQEs to investigate internal and external defects or reported issues, identify root causes, implement corrective actions, and track progress until resolution. 5. Quality Standards Guidance – Provide guidance to operators and supervisors on maintaining quality standards. 6. Documentation Updates – Develop, maintain, and/or coordinate the creation of or updates to applicable documentation. 7. In-Process Audits (IPA), Inspections, and Floor Walks – Conduct in-process audits per standards and requirements. Perform directed in-process inspections on specific orders, part numbers, or processes as determined by the Quality Department. Verify adherence to product specifications, proper procedures, and data collection requirements for new and existing products (e.g., CQA, ASP, and New Products). Also, lead manufacturing floor walks or Gemba walks. 8. Quality Reporting & Communication – Prepare the End-of-Month (EOM) Quality Update following the standard template. Update weekly quality metrics and share Quality Performance (QPs) updates on the Production Communication Board. 9. Review Board Administration – Serve as the Review Board Administrator, overseeing the review of incoming QPs and ensuring the completion of tasks and effectiveness of implemented actions. 10. Material Containment & Issue Management – Identify and implement containment measures for affected materials when necessary. 11. Product Transfers & Approvals – Support product transfer inspections, approvals, and tracking. 12. Manufacturing Floor Support – Act as a liaison between Manufacturing and other support groups (Tooling, Engineering, Sales, etc.), as well as different manufacturing areas (Plating, Stamping, Molding, Automation, HDR, etc.). 13. Training & Corrective Action Monitoring – Assist in training and monitoring production operators on specific quality concerns. Support documentation and verification of corrective actions. 14. Skills Development – take up new responsibilities assigned by manager 15. Additional Responsibilities – Occasional off shift coverage (if needed). “The responsibilities as defined are intended to serve as a general guideline for this position. Associates may be asked to perform additional tasks depending on strengths and capabilities.” Required Experience: 1. Strong data analysis skills; must be data-driven in decision-making and evaluation. 2. Solid understanding of process knowledge relevant to the assigned area. 3. Excellent problem-solving and investigative skills with a strong attention to detail. 4. Effective written and verbal communication skills. 5. Proficient in Microsoft Office applications, including Outlook, Excel, Word, and Access. 6. Collaborative team player; able to work effectively with operators, floor managers, engineers, and cross-functional teams. 7. Must be able to sit/stand for at least 90 consecutive minutes and not suffer from any sensory deprivation and/or paralysis of the limbs. Preferred Experience: 1. Previous experience in quality assurance or related field. 2. Familiarity with Samtec quality systems: QP Suite, Checkpoint, Audit Suite, etc. 3. Working knowledge of dimensional inspection tools (Micro-Vu, Drop Gage, Calipers, etc.). Required Education: High school diploma or equivalent Preferred Education: College-level education in engineering, or completion of some engineering coursework.

SAMTEC, Inc. is an Equal Opportunity Employer and committed to creating a diverse environment. All employment decisions at Samtec are based in business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, pregnancy or parental status, age, disability, sexual orientation, gender and/or gender identity/expression, marital status, past or present military service, family medical history or genetic information, or any other status protected by applicable laws.

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Join to apply for the Sr Manufacturing Quality Engineer role at ENOVIX Corporation

Join to apply for the Sr Manufacturing Quality Engineer role at ENOVIX Corporation

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• Drive the NCM Process for incoming materials to identify and disposition sources of deviation from specifications
• Collaborate on the CAPA Process to quantify defect rates and drive effective actions from suppliers
• Work with product development, Supplier Quality Engineer and Procurement team to ensure Material Engineer is properly define/updating material specifications
• Work with Technical project engineer, Process Engineer and Manufacturing teams to ensure material issued to production are fully release with all speficifications and compliances
• IPQC and OQA steps are in full compliant as per procedure, process steps, process controls, specification and inspection carried out accordingly
• Create/Update IQA & OQA control plans based on materials specifications
• Develop/Maintain inspection records and traceability for incoming materials
• Provide manufacturing quality guidance to IQA & OQA Technicians & Inspector by engaging with Supplier Quality Engineer and Process Engineers
• Own the metrology capabilities of the IQA & OQA function and coordinate its adequate calibration
• Monitor feedback and drive IQA & OQA actions based on Yield, Failure Pareto, SPC/Cpk studies from in-line manufacturing metrology
• Ensure all processes in productions and quality are in compliance with procedure at all time. Lead & Drive improvements based on audit findings and continuous improvement activities
• Design and develop quality processes, inspection, and test systems that yield predictable quality results
• Work closely with the supply chain and operations team to improve defect reporting and tracking systems
• Collaborate with Materials Engineering, Process Engineering, and Manufacturing to mitigate yield losses
• Work with R&D department to accommodate special requests for non-standard special projects materials
  
  

Responsibilities

• Drive the NCM Process for incoming materials to identify and disposition sources of deviation from specifications
• Collaborate on the CAPA Process to quantify defect rates and drive effective actions from suppliers
• Work with product development, Supplier Quality Engineer and Procurement team to ensure Material Engineer is properly define/updating material specifications
• Work with Technical project engineer, Process Engineer and Manufacturing teams to ensure material issued to production are fully release with all speficifications and compliances
• IPQC and OQA steps are in full compliant as per procedure, process steps, process controls, specification and inspection carried out accordingly
• Create/Update IQA & OQA control plans based on materials specifications
• Develop/Maintain inspection records and traceability for incoming materials
• Provide manufacturing quality guidance to IQA & OQA Technicians & Inspector by engaging with Supplier Quality Engineer and Process Engineers
• Own the metrology capabilities of the IQA & OQA function and coordinate its adequate calibration
• Monitor feedback and drive IQA & OQA actions based on Yield, Failure Pareto, SPC/Cpk studies from in-line manufacturing metrology
• Ensure all processes in productions and quality are in compliance with procedure at all time. Lead & Drive improvements based on audit findings and continuous improvement activities
• Design and develop quality processes, inspection, and test systems that yield predictable quality results
• Work closely with the supply chain and operations team to improve defect reporting and tracking systems
• Collaborate with Materials Engineering, Process Engineering, and Manufacturing to mitigate yield losses
• Work with R&D department to accommodate special requests for non-standard special projects materials
  
  

Qualifications

• Degree preference (if any), Master or PhD in Chemical, Mechanical Engineering or Substantial experience in Quality Engineering Field & Good communication skill
• Experience developing/monitoring inspection processes for incoming materials
• Experience developing control plans and managing inspection records for traceability
• Must have experience creating and driving NCM reports to final disposition and closure
• Experience reviewing incoming inspection quality records and reporting metric
• More than 5 years of experience with manufacturing and inspection systems
• Strong data processing and analytical skills (Excel, SQL, Minitab/JMP)
• Enthusiasm to get a hands-on understanding of complex problems to develop solutions
• Ability to prioritize own tasks in a dynamic, fast paced environment to maximize effectiveness
• Excellent communication and cross-functional teamwork skills
• Innate attention to detail and organization
• Understanding of electrochemistry, active materials, and portable energy solutions is a plus

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Engineering and Information Technology
• Industries Appliances, Electrical, and Electronics Manufacturing

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