Senior Quality Engineer — QA Leadership & Compliance

Boston Scientific; George Town; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking a QA Engineer to drive quality across manufacturing and product verification. You will apply problem-solving techniques, interpret drawings and procedures, and endorse decisions on nonconforming product.

The role requires a strong background in QA systems and regulatory expectations. Expect to lead CAPA investigations, participate in customer complaints, review validation data, and mentor team members.

Qualifications

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

Responsibilities

• Identify Manufacturing process defects and disposition non-conforming material.
• Participate in Customer Complaints investigations for areas under control.
• Review and approve validation data to establish specifications and performance standards.
• Provide guidance and training on complaints handling and CAPA processes.
• Promote highest levels of QA discipline and regulatory compliance.

Skills

QA engineering

Root Cause Analysis

CAPA handling

Statistical analysis

Cross-functional collaboration

Education

Bachelor's Degree in Engineering/Technology

Tools

Minitab

Excel

QMS

Job description

Boston Scientific in Penang, Malaysia, is seeking a QA Engineer to drive quality across manufacturing and product verification. You will apply problem-solving techniques, interpret drawings and procedures, and endorse decisions on nonconforming product.

The role requires a strong background in QA systems and regulatory expectations. Expect to lead CAPA investigations, participate in customer complaints, review validation data, and mentor team members.