Senior Quality Engineer (Salary up to RM10k per month)

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.; Batu Kawan; Presencial; MYR 67 000 - 112 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Daily Meal Allowance

Wellness Allowance RM2000 after Prob

EPF 15%

13-month bonus

Insurance & Medical Benefits (AIA)

Performance Bonus

18 days Annual Leave

Stock purchase plan 15% discount

Education assistance programme

Resumo da oferta

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. seeks a Senior Quality Engineer in Penang to uphold patient safety and product quality within a robust quality system.

You will ensure regulatory compliance, guide reports, and lead QA activities, including CAPAs and customer investigations. Role emphasizes problem-solving, cross-functional collaboration, and continuous improvement, with strong focus on QSR/ISO/MDD standards.

Qualificações

• Bachelor's degree in engineering.
• BSc/BE in engineering with quality focus is preferred.
• 9+ years in Operations Quality, medical device industry preferred.
• Experience in cross-functional management is essential.
• Product transfer experience is a plus.

Responsabilidades

• Apply problem-solving techniques to QA recommendations.
• Read and interpret drawings, procedures, and protocols.
• Make independent quality decisions including disposition of non-conforming products.
• Identify defects and guide corrective/preventive actions.
• Participate in customer complaint investigations and document findings.
• Provide training on complaint-handling software (GCS2).
• Support CAPAs, NCEP, and Failure Mode Investigations.
• Promote QA discipline and best practices.
• Act as go-to expert on QSR and ISO/MDD standards with escalation as needed.
• Review and approve test/validation data for new or modified products/processes.
• Champion continuous improvement from vendor selection to customer satisfaction.
• Provide guidance to Quality Engineers and technicians.
• Collaborate with EHS on environmental impacts and goals.
• Liaise with suppliers, other engineering teams, and customers.
• Be familiar with internal audit processes.

Conhecimentos

Quality Assurance

Root cause analysis

Cross-functional management

Regulatory compliance

Formação académica

Bachelor's Degree in Engineering

Ferramentas

GCS2

Descrição da oferta de emprego

Senior Quality Engineer (Salary up to RM10k per month)

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD. 4.2 View all jobs

About the Role
Demonstrate strong commitment to the Quality Policy, with a focus on patient safety and product quality, through sound daily quality practices and maintenance of an effective quality system. Ensure compliance with all relevant quality regulations, and where applicable, guide direct reports to stay current with training requirements and regulatory compliance.

Daily Meal Allowance

Flexible Wellness Allowance RM2000 cash after probation

EPF 15%

13-month bonus

Insurance & Medical Benefits (inpatient, specialist treatment , outpatient under AIA unlimited coverage)

Performance Bonus

18 days AL

Employee stock purchase plan with 15% discount

Education assistance programme and etc

Key Responsibilities

• Apply appropriate problem-solving techniques to provide sound Engineering and Quality Assurance recommendations
• Read and interpret technical drawings, procedures, and protocols
• Hold independent authority to make product quality decisions, including disposition of non-conforming products
• Identify manufacturing defects (e.g., scrap, nonconforming material, customer complaints), support root cause identification, and guide corrective/preventative actions
• Participate in customer complaint investigations within area of responsibility, documenting findings in GCS2 analysis reports
• Serve as a trainer for complaint-handling software (GCS2) as needed
• Support execution and investigation of CAPAs, NCEP, and Failure Mode Investigations
• Promote high standards of QA engineering discipline and best practices
• Act as a go-to expert on QSR and ISO/MDD standards, escalating critical decisions to the Quality Engineering Manager/Site QA Director as needed
• Apply strong expertise in validation engineering and regulatory requirements
• Review and approve test/validation data to establish technical specifications for new or modified products/processes
• Champion continuous improvement and quality initiatives from vendor selection through to customer satisfaction
• Provide technical guidance to Quality Engineers, Associate Quality Engineers, and technicians/inspection staff
• Collaborate with EHS to identify environmental impacts and set related goals/targets
• Liaise with suppliers, other engineering teams, and customers as needed
• Be familiar with internal audit processes

Job Requirements

• Bachelor's Degree in Engineering
• Minimum 9 years of experience in Operations Quality; medical device industry experience preferred
• Strong grasp of quality operations fundamentals, including risk assessment and data analysis for root cause identification
• Skilled in using standard problem-solving tools and communicating findings clearly
• Experience in cross-functional management
• Experience in product transfer is an advantage

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.