Senior Quality FG Engineer II - Process & Compliance

Boston Scientific

George Town

On-site

MYR 60,000 - 120,000

Full time

14 days+

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Job summary

Boston Scientific in Penang, Malaysia is seeking a Quality Engineer to drive conformity and reliability in manufacturing. You will scrutinize test results, interpret drawings, and lead investigations into non-conforming materials and customer complaints.

This role requires strong analytical skills and hands-on QA experience in a regulated environment. Collaborate with cross-functional teams to implement corrective actions, support validations, and ensure compliant product releases.

Qualifications

Undergraduate Degree in Science, Material Engineering, or related discipline.
Minimum 3 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.

Responsibilities

Identify and resolve complex deviations and non-conformities in manufacturing.
Prepare analyses and reports from test results and process findings.
Read and interpret technical drawings, procedures, and protocols.
Disposition non-conforming material and assist root-cause analysis and corrective actions.
Collaborate with process owners to bound product stops and document release criteria.
Make decisions related to product quality including disposition of non-conforming product.
Participate in customer complaints investigations for areas under control.
Document investigation findings in analysis reports and quality records.
Provide guidance to junior QA staff and technicians.
Drive improvements in product and process quality through CAPAs and Lean principles.