Senior Quality Engineer (Medical Devices) - Impact & Growth

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.; Batu Kawan; On-site; MYR 67,000 - 112,000; Full time

Benefits offered by this job

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Root cause analysis

Cross-functional management

Regulatory compliance

Education

Bachelor's Degree in Engineering

Tools

GCS2

Job description

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.