Senior Quality Engineer - Finished Goods & Process

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 90,000 - 140,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a Senior Quality Engineer to lead complex quality activities in a regulated manufacturing environment, focusing on product release, IQA/IQC, CAPA investigations and validation of equipment and test methods.

You will work with Manufacturing, Engineering and QA teams to drive improvements, ensure conformity to QSR/ISO standards, and uphold high standards for process validation and risk management.

Qualifications

• Undergraduate Degree in Science, Material Engineering, or a related discipline.
• Minimum 5 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in Incoming Quality Assurance (IQA) and Outgoing Quality Inspection.
• Experience in equipment qualification and test method validation.
• Experience supporting material issue management and product release activities.
• Strong stakeholder management and communication skills.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results.
• Read and interpret technical drawings, procedures, and protocols.
• Dispositions non-conforming material and identifies root causes; supports CAPAs and changes.
• Ensures product quality decisions and release criteria are met.
• Participates in investigations for customer complaints and quality events.
• Supports validation protocols and reports; collaborates with multiple functions.

Skills

Stakeholder management

Analytical thinking

Statistical analysis

Problem solving

Cross-functional

SAP knowledge

Drawing interpretation

Risk assessment

Equipment qualification

Test method validation

Education

Bachelor's degree in Science or related

Tools

SAP

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a Senior Quality Engineer to lead complex quality activities in a regulated manufacturing environment, focusing on product release, IQA/IQC, CAPA investigations and validation of equipment and test methods.

You will work with Manufacturing, Engineering and QA teams to drive improvements, ensure conformity to QSR/ISO standards, and uphold high standards for process validation and risk management.