Key Responsibilities:
QMS & Audits: Lead QMS improvements and manage the Internal Audit program.
Design Assurance: QA representative for NPD; review/approve DHF, V&V, and Design Inputs/Outputs.
Risk Management: Lead ISO 14971 activities, including dFMEA and pFMEA.
Change Control: Evaluate product/process changes and perform regulatory assessments (FDA/MDR).
CAPA & Complaints: Lead root cause investigations for NCs, CAPAs, and customer complaints (Vigilance/MDR).
Validation: Oversee IQ/OQ/PQ for manufacturing, software, and microbiology.
Requirements: Requirements:
B.Sc. in Engineering or Life Sciences.
5-8 years of QA experience in the Medical Device industry (Class II).
Expertise in ISO 13485:2016, EU MDR, and FDA 21 CFR Part 820.
Strong leadership in ISO 14971 (Risk Management).
Experience with DHF, Change Control, and V&V frameworks.
Certified Internal Auditor - an advantage.
(Proven skills in Root Cause Analysis (CAPA/NC)
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This position is open to all candidates.
