Senior Quality Engineer – FG & Process Improvement

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 67,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. invites applications for a Quality Engineer role based in Penang.

You will identify defects, analyze test results, and interpret drawings, procedures, and protocols to drive improvements in product and process quality. The role requires a minimum of 3 years in quality engineering within a regulated manufacturing environment, familiarity with IQA/OQA, and strong problem-solving skills.

Qualifications

• Undergraduate degree in Science, Materials or a related discipline.
• Minimum 3 years of Quality Engineering experience in a regulated manufacturing environment.
• Experience with IQA, OQA, equipment qualification and test method validation.

Responsibilities

• Identify and resolve complex exceptions to work assignments.
• Perform incoming/outgoing quality inspections of materials and finished goods.
• Review and develop process validation protocols and reports.
• Lead investigations of customer complaints and CAPAs; support root cause analysis.
• Ensure compliance with QSR/ISO/MDD and regulatory requirements.
• Provide guidance to technicians and engineers and mentor staff.

Skills

Stakeholder management

Communication skills

Analytical thinking

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Science/Materials

Tools

SAP

Six Sigma/Quality tools

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. invites applications for a Quality Engineer role based in Penang.

You will identify defects, analyze test results, and interpret drawings, procedures, and protocols to drive improvements in product and process quality. The role requires a minimum of 3 years in quality engineering within a regulated manufacturing environment, familiarity with IQA/OQA, and strong problem-solving skills.