Quality Engineer II
Core
Provide design quality engineering support for medical device product development and sustaining engineering activities, ensuring compliance with quality system regulations and risk management requirements.
Role type
Quality Engineer II (Medical Devices)
Builds
Medical devices and related quality documentation
Domain
Healthcare / Medical Devices / Regulated Manufacturing
Required skills
Design controls, Risk management (ISO 14971), FDA QSR, EU MDR, Statistical tools (Minitab, ANOVA, GR&R), Process validation (IQ/OQ/PQ), DFMEA, PFMEA
Preferred skills
ASQ CQE/CQA/CSQE/CRE, ISO 9001/13485 Auditor, Lean Six Sigma Green/Black Belt, DMAIC/DFSS
Technologies
Minitab, ISO 14971, ISO 13485, FDA QSR, EU MDR, IEC 60601, 21 CFR Part 820, 21 CFR Part 11
Responsibilities
Review design documentation for quality characteristics; Ensure compliance with FDA QSR, EU MDR, and internal requirements; Develop and maintain risk management documentation (Risk Plans, Hazard Analyses, DFMEA); Support design verification and validation activities; Review Design History Files and Technical Files; Support product transfer through process validation; Develop quality system templates and training materials; Participate in internal and external audits.
Seniority
Mid-level, hands-on IC