Quality Engineer II
Core
Lead validation strategies and quality initiatives for new product introductions, technology implementations, and manufacturing changes to ensure compliance and product quality in regulated industries.
Role type
Quality Engineer II (Regulatory Validation & Process Qualification)
Builds
Validated manufacturing processes, equipment, and test methods for medical devices or pharmaceutical products.
Domain
Medical devices / Pharmaceuticals / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP, GAMP, ISO 13485, Process Validation (IQ/OQ/PQ), Computer System Validation (CSV), Test Method Validation (TMV), manufacturing equipment lifecycle management, design transfer, new product introduction (NPI)
Preferred skills
Experience in medical device or pharmaceutical industry, knowledge of new product launches
Technologies
IQ, OQ, PQ, CSV, TMV
Responsibilities
Lead validation strategies for new product introductions and technology implementations; Plan, execute, and review Process Validation (IQ, OQ, PQ) and Computer System Validation (CSV); Develop and review Test Method Validations (TMV); Ensure compliance with GxP, GAMP, ISO 13485, and internal quality standards; Provide technical expertise on manufacturing equipment and processes.
Seniority
Mid-level, hands-on IC
