Senior Quality Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 180,000 - 260,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks an experienced QA Engineering leader to drive quality decisions, investigations and CAPA programs across cross-functional teams.

The role emphasizes adherence to ISO 13485, QSR, and MDD requirements, with strong problem-solving and guidance to engineers, technicians, and inspectors. The ideal candidate will have a minimum of 9 years in Operations Quality within medical devices, and hands-on ISO 13485 experience, contributing

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• Experience leading quality investigations (CAPA, NCEP, nonconformance).
• Strong knowledge of validation, risk assessment, data analysis, QSR, and ISO/MDD requirements.
• Ability to guide engineers, technicians and inspectors across cross-functional teams.

Responsibilities

• Selects techniques for problem solving and provides QA recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Has authority to disposition non-conforming product and determine quality decisions.
• Identify defects, root causes and corrective actions; support product release criteria.
• Lead customer complaints investigations and document findings.
• Provide training on software-related complaints handling (GCS2) as required.
• Support CAPAs, NCEP, failure investigations and related analyses.
• Guide others in QA discipline and promote best industry practices.
• Collaborate with internal teams and suppliers; participate in audits and reviews.
• Review and approve validation data to establish specifications for new/modified processes.

Skills

Leadership

Problem solving

Cross-functional collaboration

Technical guidance

Education

Bachelor’s degree in Engineering or Science

Job description

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understandsand complieswith all the regulations governing the quality systems. Ensurestheir direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Job Description:

Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.

Read and interpret technical drawings, procedures, and protocols

Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.

Participates in Customer Complaints investigation for areas under their control.

Document investigation findings in analysis report on GCS2

Become a trainer for the Software related with complaints handling process (GCS2), as required.

Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.

Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decision.

Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.

Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.

Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.

Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.

Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.

Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.

Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.

Is familiar with the internal auditing process.

Job Requirements:

Bachelor’s Degree in Engineering, Science, or related field.

Minimum 9 years of experience in Operations Quality, preferably within the medical device industry.

Minimum 3 years of hands-on ISO 13485 experience.

Experience in nonconforming product disposition and quality decision-making.

Strong experience leading complaint, CAPA, NCEP/nonconformance, and failure investigations, including root cause analysis.

Strong knowledge of validation, risk assessment, data analysis, QSR, and ISO/MDD requirements.

Ability to provide technical guidance to engineers, technicians, and inspectors and work effectively with cross-functional teams.

Experience supporting or conducting internal quality audits.

Product transfer experience is an added advantage.

Strong problem-solving, communication, and cross-functional management skills.

This is an additional headcount for expansion.

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

Your work can make a difference.

Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.

For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies

And Penang is part of that global story.

Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.

Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.

Your work can make a difference.

Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.

For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies

And Penang is part of that global story.

Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.

Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.