Senior Engineer, Product Quality
Core
Senior Product Quality Engineer ensuring GMP/ISO compliance, managing supplier quality, and leading product release/rejection decisions.
Role type
Senior IC product quality engineer
Builds
compliant medical device products and components
Domain
Medical devices / Manufacturing quality
Required skills
GMP compliance, ISO standards, PPAP, FMEA, MSA, SPC, supplier quality management, non-conformance handling, audit participation, Lean philosophy
Preferred skills
Engineering degree, 5+ years QA experience, training skills, Excel proficiency
Technologies
Excel
Responsibilities
Ensure GMP and Regulatory compliance; Stop processing and lead complaint handling for non-conforming products; Implement corporate quality policies; Define and approve inspection/testing standards; Develop regulatory guidelines; Train staff on GMP/ISO/QA; Conduct internal audits; Release or reject products/components; Manage supplier quality issues and performance; Liaise with Manufacturing and Engineering groups.
Seniority
Senior, hands-on IC