Base: 75.000 eur to 118.450 eur; bonus/equity: not...
Capa and nonconformance processes
Root cause analysis methodologies
Iso 13485 and eu mdr
Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies
Job Summary
Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies.
Oversee the end-to-end CAPA and NC process, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.
Contribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, work instructions, and templates.
Matching Summary
Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies.
Salary
Base: 75.000 EUR to 118.450 EUR; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
CAPA and Nonconformance processes
Root cause analysis methodologies
ISO 13485 and EU MDR
Risk management in accordance with ISO 14971
Quality Management System (QMS)
Nice-to-have
Ability to influence cross-functional teams
Drive quality culture
Technologically Savvy
Key Requirements
Bachelor’s degree in Engineering, Life Sciences, or related field
Minimum 5–7 years of experience in quality engineering
Deep understanding of FDA QSR (21 CFR Part 820)
Proven experience managing CAPAs and NCs
Strong analytical skills and proficiency in quality tools