Quality Manager - medical devices
- Provincia di Milano
- 55.000-60.000 € all'anno
- Tempo indeterminato
- Full time
- Ensure product and process quality on the production floor, including in-process controls, final inspections, product release, and handling of manufacturing deviations.
- Lead and support investigations for nonconformances, complaints, and deviations; drive root cause analysis and implement effective corrective and preventive actions (CAPAs).
- Coordinate with the Quality System Manager to ensure QMS elements (e.g., documentation, audits, training, change control, risk management) are properly implemented and maintained.
- Support validation activities related to manufacturing processes, equipment, and test methods to ensure compliance with GMP and regulatory requirements.
- Act as the quality interface between production, engineering, regulatory, and supply chain teams to resolve quality issues, support design transfer, and ensure compliant operations.
- Monitor and report quality performance indicators (e.g., defect rates, yield, complaints), identify trends, and lead improvement initiatives.
- Ensure readiness for internal and external audits; support audit execution and timely resolution of findings.
- Contribute to continuous improvement across quality processes, manufacturing practices, and documentation standards.
- Provide strong leadership to quality and production teams, ensuring clear guidance and performance oversight.
- Bachelor's degree in engineering, life sciences, or related field.
- Minimum 8 years of experience in quality management within the medical device industry.
- Proven experience in managing cross-functional teams in a regulated manufacturing environment.
- Experience with EtO sterilization process and related validation activities.
- In-depth knowledge of EU MDR 2017/745, ISO 13485, FDA 21 CFR Part 820, MDSAP, and risk management (ISO 14971).
- Experience with QMS implementation, maintenance, and improvement.
- Strong problem-solving skills and experience with tools : 8D, Fishbone, FMEA, etc.
- Excellent communication, organizational, and leadership skills.
- Excellent written and spoken English.