Senior Quality Engineer - FG/RI, Process & Compliance

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

Job summary

Boston Scientific Corporation is seeking a Quality Engineer to lead investigations, approve dispositions of non-conforming material, and drive CAPA, NCEP and validation activities across manufacturing. You will analyze results, interpret drawings, and collaborate with process owners to ensure product quality meets regulatory standards.

Requires undergraduate degree in Science or Materials, 5+ years in regulated quality engineering, IQA/OQ experience, equipment qualification, and strong

Qualifications

• Minimum 5 years of quality engineering in a regulated manufacturing environment.
• Experience in Incoming Quality Assurance and Outgoing Quality Inspection.
• Experience in equipment qualification and test method validation.
• Experience supporting material issue management and product release activities.

Responsibilities

• Identify defects and disposition non-conforming materials.
• Participate in customer complaints investigations within your control.
• Review and develop process validation protocols and reports.
• Drive improvements in product and process quality.
• Provide guidance to Associate Quality Engineer, Technician and Inspection staff.
• Collaborate with Manufacturing, Engineering, Materials and QA stakeholders.

Skills

Stakeholder management

Communication skills

Quality problem solving

Root cause analysis

Data-driven decisions

Statistical analysis

Lean principles

Six Sigma

Risk assessment

Cross-functional collaboration

Education

Undergraduate Degree in Science or Materials

Tools

SAP

Engineering drawing interpretation

Test method validation

Job description

Boston Scientific Corporation is seeking a Quality Engineer to lead investigations, approve dispositions of non-conforming material, and drive CAPA, NCEP and validation activities across manufacturing. You will analyze results, interpret drawings, and collaborate with process owners to ensure product quality meets regulatory standards.

Requires undergraduate degree in Science or Materials, 5+ years in regulated quality engineering, IQA/OQ experience, equipment qualification, and strong