Senior Quality Engineer – FG & IQA Leadership

Boston Scientific; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking an experienced Quality Engineer to ensure product quality across the manufacturing and testing environment. You will lead IQA and OQ efforts, review non-conformances, and drive CAPA investigations while collaborating with Manufacturing, Engineering and Suppliers to resolve complex issues.

The role requires an undergraduate science degree and at least five years in regulated QA, with strong data analysis, risk assessment, and knowledge of GMP/ISO

Qualifications

• Undergraduate degree in Science, Material, or related discipline.
• Minimum 5 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in IQA and OQ activities and product release.
• Experience supporting material issue management and release decisions.
• Knowledge of GMP/ISO and regulatory requirements.

Responsibilities

• Identify and resolve complex exceptions to work assignments.
• Summarize, analyze, and draw conclusions from test results and process findings.
• Read and interpret technical drawings, procedures, and protocols.
• Disposition non-conforming material and support root cause investigations.
• Dispositions decisions related to product quality and release criteria.
• Participate in customer complaints investigations and document findings.
• Drive CAPA, NCEP, and FMEA activities and improvements.
• Mentor and guide Associates in QA activities and inspection staff.

Skills

Stakeholder mgmt

IQA experience

OQ validation

Product release

Root cause analysis

Data-driven decisions

SAP knowledge

Cross-functional collab

Risk assessment

Statistical analysis

Manufacturing liaison

Education

BSc in Science or related

Tools

SAP

Job description

Boston Scientific in Penang, Malaysia, is seeking an experienced Quality Engineer to ensure product quality across the manufacturing and testing environment. You will lead IQA and OQ efforts, review non-conformances, and drive CAPA investigations while collaborating with Manufacturing, Engineering and Suppliers to resolve complex issues.

The role requires an undergraduate science degree and at least five years in regulated QA, with strong data analysis, risk assessment, and knowledge of GMP/ISO