Senior Quality Engineer — Medical Devices, QMS & CAPA Leader

Boston Scientific Gruppe; Penang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific in Penang seeks a Quality Engineer to support QA activities in a regulated medical device context. You will review processes, approve nonconforming material, and drive CAPA investigations to safeguard patient safety and product quality.

Collaborating with cross-functional teams, you will validate changes and maintain compliance with ISO 13485 and related standards. Strong analytical and documentation skills are essential.

Qualifications

• Bachelor's Degree in Engineering, Technology, or related Science.
• 4–5 years of experience in a regulated industry, preferably medical device.
• Experience reviewing nonconforming event risk assessments and investigations.
• Strong understanding of quality systems and regulatory requirements.
• Strong analytical mindset with proven problem-solving capability.

Responsibilities

• Selects techniques for problem solving and provides QA recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Decides on product quality disposition for non-conforming material.
• Identify manufacturing defects and support CAPA investigations.
• Participate in Customer Complaints investigations within scope.
• Document investigation findings and report in system.
• Provide training related to complaints handling (GCS2) as required.
• Support CAPAs, NCEP, and Failure Mode Investigations execution and inquiry.
• Promote QA discipline and regulatory compliance within the team.
• Governs QA decisions with reference to Quality Director as final arbiter.
• Lead validation engineering activities and ensure regulatory compliance.

Skills

ISO 13485

QMS

Root Cause Analysis

CAPA

NCEP

Failure Mode Investigation

Data analysis

Minitab

Excel

Nonconformance management

Cross-functional collaboration

Validation

Education

Bachelor's Degree in Engineering

Tools

Minitab

Excel

Job description

Boston Scientific in Penang seeks a Quality Engineer to support QA activities in a regulated medical device context. You will review processes, approve nonconforming material, and drive CAPA investigations to safeguard patient safety and product quality.

Collaborating with cross-functional teams, you will validate changes and maintain compliance with ISO 13485 and related standards. Strong analytical and documentation skills are essential.