2,518 Quality Supervisor jobs in Malaysia

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At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

The Quality Supervisor is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 11137 and and other applicable regulatory standards.

The Quality Supervisor leads a team of Technicians, Senior Technicians and Analysts/Engineers. This role owns and directs complaint/non-conformance/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role recommends, plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

By providing direction to the Analysts/Engineers and Technicians, the Quality Supervisor develops and manages work assignments, analyzes and trends quality system performance and is responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

In addition, the Quality Supervisor can delegate for the Quality Manager as designated signatory when QM are not available

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians and Quality Analysts/Engineers by providing technical support, mentoring and oversight of assigned duties and objectives.
• Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians and Analysts/Engineers.
• Based on facility staffing, the Quality Supervisor may be responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non conformance investigations
• Reviews and recommends approval for protocols and final reports generated through the or EBeam Tech Center for sterilization process validations.
• Reviews the current quality system and recommend / implement improvements as needed. Develops analyses and reports on the performance of the quality system.
• Uses data to perform statistical analysis and recommend process changes to improve service quality.
• Leads the site's bowler/countermeasure process for annual quality objectives.
• Leads projects focused on quality system and service quality improvements.
• Leads and supports internal and external quality system audits including regulatory authorities, notified bodies and Customers. Performs supplier audits and internal audits at other AST facilities. Responsible for managing internal and external audit observation follow-up process for the facility.
• Leads process and product corrective actions and problem-solving activities.
• Instructs and directs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Perform all other duties as assigned.

Bachelor's Degree in Science

• 6-8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 6-8 years of experience with medical device or other regulated industries preferred.
• 6-8 years of experience working in an ISO certified environment required.
• 2-3 years supervisory/project leadership/oversight required
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 18,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.

Job Segment: Facilities, Quality Engineer, Infection Control, Medical Device, Operations, Quality, Engineering, Healthcare

Overview

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

The Quality Supervisor is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 11137 and other applicable regulatory standards.

The Quality Supervisor leads a team of Technicians, Senior Technicians and Analysts/Engineers. This role owns and directs complaint/non-conformance/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role recommends, plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

By providing direction to the Analysts/Engineers and Technicians, the Quality Supervisor develops and manages work assignments, analyzes and trends quality system performance and is responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

In addition, the Quality Supervisor can delegate for the Quality Manager as designated signatory when QM are not available.

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians and Quality Analysts/Engineers by providing technical support, mentoring and oversight of assigned duties and objectives.
• Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians and Analysts/Engineers.
• Based on facility staffing, the Quality Supervisor may be responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non conformance investigations.
• Reviews and recommends approval for protocols and final reports generated through the EBeam Tech Center for sterilization process validations.
• Reviews the current quality system and recommend / implement improvements as needed. Develops analyses and reports on the performance of the quality system.
• Uses data to perform statistical analysis and recommend process changes to improve service quality.
• Leads the site's bowler/countermeasure process for annual quality objectives.
• Leads projects focused on quality system and service quality improvements.
• Leads and supports internal and external quality system audits including regulatory authorities, notified bodies and Customers. Performs supplier audits and internal audits at other AST facilities. Responsible for managing internal and external audit observation follow-up process for the facility.
• Leads process and product corrective actions and problem-solving activities.
• Instructs and directs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Perform all other duties as assigned.

• Bachelors Degree in Science (Required).
• 6-8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 6-8 years of experience with medical device or other regulated industries preferred.
• 6-8 years of experience working in an ISO certified environment required.
• 2-3 years supervisory/project leadership/oversight required.
• Sterilization experience preferred.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Excellent problem-solving skills.
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 18,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.

Job Requirements:

• Preferably 1-2 year(s) of working experience in related field
• Able to handle and prioritize multiple tasks simultaneously in a fast-paced manufacturing environment.
• Applicants must be willing to work in SENAI, Johor area.

Job Responsibilities:

• Conduct daily department compliance report.
• Planning and leading IPQC on daily inspection guidance.
• Assist the engineering team for any products and department improvement.
• Ensure production running follow procedure and systematic.

1. Determines and distributes work assignments/priorities.
2. Supervise quality control team and compliance activities to achieve company objectives.
3. Maintain the department procedures to ensure that process changes are documented.
4. Review production schedules and related information and plan and determine the quality control support.
5. Performs data review/editing of analytical results produced by inspectors.
6. Acts as advisor to team members to meet schedules and resolve instrument problems.
7. Leads, managers, and/or participants in the investigation of non-conformances in compliance with quality requirements.
8. Ensure adequate training (skill-based, and Safety) for employees within the department, to support production needs.
9. Provides technical QC expertise at the site, within and outside of the department at designated site(s).
10. Organize and manage special projects as needed.
11. Escalate and initiate product quality investigations.
12. Ability to successfully work on a cross-functional basis with other site supervisors.
13. Responsible for the end-month stock take for the Quality department.
14. Any other duties as assigned from time to time.

Requirement:-

1. At least Diploma in Quality Assurance, Industrial, Mechatronic or Mechanical engineering.
2. 2 years and above of experience in quality engineering, quality assurance or similar role. Having working experience in sheet metal is an added advantage.
3. Strong communication and interpersonal skills.
4. Strong analytical and problem-solving skills.
5. Computer proficiency in MS office applications.
6. Knowledge Internal Audit Knowledge & ISO standards is an added advantage.
7. Good verbal and written communication in English and Malay.
8. Able to work independently with minimum supervision.

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Supervisor located in Flex PTP.

Reporting to the Quality Manager the Quality Supervisor role is responsible to supervises and coordinates activities related to the Quality Assurance Inspection function, on the manufacturing floor. Quarantine and disposition of nonconforming goods, while ensuring the policies and processes are followed.

What a typical day looks like:

• Assigns employees to maximize quality control goals.

• Ensures that directed shift staffing levels are maintained.

• Hires guiders and inspectors for shift.

• Interfaces with HR and finance for employee issues.

• Research data and puts corrective actions into place.

• Reviews quality reports.

• Performs process and sub factory audits.

• Ensures procedures are followed and may develop procedures for the quality assurance inspection operation.

• Provides immediate supervision and guidance to inspectors, checking work at frequent intervals.

• Frequently interacts with outside customers, vendors and functional peer groups at various management levels and serves as a liaison between customer and the division regarding quality issues.

• Directs daily shift activities.

• Confers with management and production to define and hold up quality goals.

• Trains shift guidance to inspectors in quality processes.

• Holds up engineering and other functionalities in correcting employee errors.

The experience we're looking to add to our team:

• Minimum of a Bachelor's Degree in electrical engineering, mechanical engineering or similar field.

• Typically requires at least 5 years of experience in Quality in the high technology electronics industry or related area.

Responsibilities:

• Assist the manager in setting quality goals and effectively promoting and implementing them.
• Monitor the validity and completeness of quality-related inspection standards and documents.
• Organize and resolve quality issues during packaging and shipping, handle quality anomalies, and implement quality improvements.
• Responsible for handling production quality anomalies and customer complaints, ensuring the effectiveness of corrective and preventive measures.
• Responsible for organizing and supervising relevant departments to analyze quality issues during production, develop improvement measures, and track the effectiveness of these measures.
• Responsible for organizing and implementing the rectification of quality issues during internal and external product and audit processes.
• Train and motivate subordinates, conduct regular assessments and coaching of subordinates, and make recommendations on job adjustments, training, salary adjustments, promotions, appointments, and dismissals.
• Complete other related tasks assigned by supervisors.

Requirements:

• Bachelor's degree or above
• At least three years of relevant experience in quality management
• Excellent communication and negotiation skills
• Strong execution and willingness to work overtime
• Understanding and familiarity with common quality tools and standards, such as ISO 9001, IATF 16949, ISO 45001, ISO 14001, Five Core Tools, QC Seven Tools, VDA 6.3, or VDA 6.5
• Fluent listening, speaking, reading, and writing in Malay, English, and Chinese (essential for dealing with Chinese customers and suppliers)
• Proficient in Microsoft Office, Excel, Word, and PowerPoint.