Senior Quality Engineer — Medical Devices, CAPA & Validation

Boston Scientific; George Town; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific in Penang, Malaysia seeks a Quality Assurance Engineer to ensure product quality in a regulated medical device environment. You will interpret drawings, perform CAPAs, NCEP, and FMEA engagements, and mentor QA staff.

You will lead investigations into nonconformances and ensure documentation aligns with ISO 13485 and QMS requirements. With 4–5 years in a regulated industry, you will collaborate across functions to drive improvements, validate processes, and support customer

Qualifications

• Bachelor's Degree in Engineering, Technology, or related Science.
• 4–5 years of QA experience in a regulated industry.
• Experience in reviewing nonconforming event risk assessments.
• Strong understanding of ISO 13485 and QMS.
• Experience with validation lifecycle and CAPA processes.

Responsibilities

• Selects techniques for problem solving and QA recommendations.
• Read and interpret drawings, procedures, and protocols.
• Decides product quality disposition for non-conforming material.
• Identify manufacturing defects and support CAPA actions.
• Participates in customer complaints investigations.
• Documents investigation findings in analysis reports.
• Provides training related to complaints handling.
• Supports CAPAs, NCEP, and Failure Mode Investigations.
• Promotes QA discipline and best practices.
• Leads in QSR and ISO/MDD compliance within the group.
• Reviews and approves validation data.
• Drives continuous improvement from vendor selection to customer satisfaction.
• Gives technical guidance to QA staff.

Skills

ISO 13485

RCA

CAPA

NCEP

Validation lifecycle

Nonconformance mgmt

Failure Mode Investigation

Cross-functional collaboration

Education

Bachelor's Degree in Engineering, Technology, or related Science

Tools

Excel

Minitab

Documentation review

Job description

Boston Scientific in Penang, Malaysia seeks a Quality Assurance Engineer to ensure product quality in a regulated medical device environment. You will interpret drawings, perform CAPAs, NCEP, and FMEA engagements, and mentor QA staff.

You will lead investigations into nonconformances and ensure documentation aligns with ISO 13485 and QMS requirements. With 4–5 years in a regulated industry, you will collaborate across functions to drive improvements, validate processes, and support customer