230 Quality Management System jobs in Malaysia

As a Quality Management System Coordinator at Melexis, you will be part of the global Quality Management System Team, supporting both site and corporate quality objectives.

• Contribute to the Annual Audit Strategy and Planning to support site and audit processes
• Support and/or lead internal audits (certification, customer) audits on site in accordance with relevant Quality and Environmental standards (e.g. ISO 9001, ISO 14001, IATF 16949 and VDA 6.3)
• Collect, maintain, and communicate product-related environmental documentation to customers
• Ensure timely and accurate preparation of environmental declarations such as Conflict Minerals, RoHS, and others
• Execute the local environmental strategy in alignment with local management to ensure compliance with legal requirements and ISO 14001, supporting Melexis’ sustainability goals

• Bachelor’s degree, preferably in Chemistry or a related technical field
• Minimum 3 years of experience in a similar role, ideally within the automotive industry
• Sound knowledge of Management Systems standards (e.g. ISO 9001, ISO 14001, IATF 16949, VDA 6.3) and related core tools; having an auditor certification or card is an advantage
• Strong ability to plan, analyze, implement, and follow up on quality and environmental initiatives
• Detail-oriented with a strong work ethic and the ability to work independently with minimal supervision
• Excellent written and verbal communication skills, with the ability to communicate effectively across diverse audiences
• Ability to multi-task, remain flexible, and deliver results in a deadline-driven environment
• Fluency in English is required; proficiency in Chinese is an added advantage

• A challenging job in a dynamic, high-tech international environment;
• The opportunity to take ownership of your professional passion and contribute to the success of the company;
• An enjoyable, team-oriented, and professional atmosphere in a flat-structured organization;

Melexis is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, colour, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company.

Inspired by a passion for technology and engineering, Melexis designs, develops and delivers innovative micro-electronic solutions. They enable designers to turn ideas into applications that support the best imaginable future. The company’s advanced mixed-signal semiconductor sensors and actuators integrate sensing, driving and communication into next-generation products and systems. They improve safety, raise efficiency, support sustainability and enhance comfort.

Melexis is a world leader in automotive sensors. Today, on average, every new car produced worldwide contains 18 Melexis chips. Melexis uses this expertise to serve other markets as well: alternative mobility, smart appliances, smart buildings, robotics, energy management and digital health.

Melexis is headquartered in Belgium and employs over 2000 people in 18 locations worldwide. The company is publicly traded on Euronext Brussels (MELE).

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OVERALL PURPOSE OF THE JOB

Responsible for developing, implementing, and maintaining the project’s Quality Management System (QMS). This includes preparing the Project Quality Plan (PQP), Inspection and Test Plans (ITPs), field inspection and testing procedures, internal and external audit plans, and overseeing document control processes to ensure full compliance with contractual and regulatory quality requirements.

PRINCIPLE DUTIES

• Develop and implement the Quality Management System (QMS), Project Quality Plan (PQP), and Inspection & Test Plans (ITPs).
• Conduct inspections and testing for materials, fabrication, welding, coating, and installation activities.
• Identify and manage non-conformances (NCRs), including root cause analysis and corrective actions.
• Plan and perform quality audits on internal teams, vendors, and subcontractors.
• Maintain proper documentation, traceability, and quality records in line with project and client requirements.
• Liaise with client representatives, third-party inspectors, and project team on all quality matters.
• Ensure QAQC compliance with HSE standards and contribute to continuous improvement initiatives.

KNOWLEDGE / EXPERIENCE REQUIRED FOR THE JOB

• Minimum 6 years of experience in the oil and gas industry, with at least 3 years as a QAQC Engineer,
• Experienced in quality audit of oil and gas project execution during procurement, and construction.
• Familiar with international materials standards, pressure/process piping and vessels codes, structural and electrical codes, welding, and NDT codes such as ASME, AWS, ANSI and API, etc.

ACADEMIC / PROFESSIONAL QUALIFICATION

• Diploma in Engineering or equivalent.
• CSWIP 3.1/ PCN level I or equivalent is preferred.
• Attended International Register of Certified Auditors (IRCA) certified ISO 9001 Lead Auditor Cour

• Seniority level Executive

• Employment type Contract

• Job function Quality Assurance
• Industries Oil and Gas

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The Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.

1) DTI Values

-Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities.

2)Project Systems Support

-Assist the Project Quality & Completions Manager/s to:

-Develop the register of Project contract completions & handover requirements and track progress against deliverable development.

-Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into -ACC/Gdos and developing the project folder structure as required.

3)Project Quality Assurance

-Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.

-Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.

-Assist with the upload of records to the Gdos and ACC system.

4)Coaching and Training

-Assist project team members to understand the functionality of ACC and Gdos.

-Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.

-Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis.

5)Reporting

-Reporting and Communication:

-Provide project reporting to assist the team to have visibility of the status of quality and completions records.

-Provide input to project monthly reporting as required.

• Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
• Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
• Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.

Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.

Experience:

• Ability to speak, write and understand the English language in relation to construction terminology.
• Ability to work independently and collaboratively in a dynamic environment.
• Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.

Ability to administer multiple and competing tasks concurrently.

Skills & Knowledge:

• Professional presentation and conduct.
• Ability to prepare reports and communicate required actions to team members.
• Proficient in using Power BI to report against required outcomes.
• To have high levels of self-discipline, self-motivation, and energy.
• Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.

Ability to embrace DTI’s values.

Minimum 5 years experience

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2022 Gamuda Berhad (29579-T). All rights reserved.

Regular/Temporary: Permanent

Location: Petaling Jaya, 10, MY, 47820

The Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.

1. DTI Values
   - Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities.
2. Project Systems Support
   - Assist the Project Quality & Completions Manager/s to:
   - Develop the register of Project contract completions & handover requirements and track progress against deliverable development.
   - Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into ACC/Gdos and developing the project folder structure as required.
3. Project Quality Assurance
   - Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.
   - Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.
   - Assist with the upload of records to the Gdos and ACC system.
4. Coaching and Training
   - Assist project team members to understand the functionality of ACC and Gdos.
   - Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.
   - Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis.
5. Reporting
   - Provide project reporting to assist the team to have visibility of the status of quality and completions records.
   - Provide input to project monthly reporting as required.

• Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
• Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
• Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.

Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.

Experience:

• Ability to speak, write and understand the English language in relation to construction terminology.
• Ability to work independently and collaboratively in a dynamic environment.
• Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.

Ability to administer multiple and competing tasks concurrently.

Skills & Knowledge:

• Professional presentation and conduct.
• Ability to prepare reports and communicate required actions to team members.
• Proficient in using Power BI to report against required outcomes.
• To have high levels of self-discipline, self-motivation, and energy.
• Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.

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.