Senior Manufacturing Quality Engineer (1-Year Contract)
medtronic · Yoqneam Illit
وصف الوظيفة
About the role
Medtronic is hiring a Senior Manufacturing Quality Engineer for a temporary, 1-year contract in Yoqneam Illit. The role ensures that Class III medical devices are manufactured in compliance with internal quality standards, regulatory requirements and Medtronic's commitment to patient safety. It works closely with Manufacturing, Operations, R&D and Supply Chain to drive quality improvements on the production floor.
Key responsibilities
- Maintain and improve the Quality Management System in line with ISO 13485, EU MDR and FDA QSR (21 CFR 820).
- Support operations activities including manufacturing, validation, MRB and CAPA.
- Oversee CAPA, nonconformances, deviations, complaints, risk management, change controls, document control and training.
- Take part in internal and regulatory audits, including preparation, execution and follow-up.
- Collaborate with R&D, Regulatory Affairs, Operations and Supply Quality teams.
- Review and approve documentation, work instructions and SOPs, support risk assessments and production and engineering validation activities.
- Lead investigations of nonconformances, deviations and CAPAs, including root cause analysis and corrective and preventive actions.
Required profile
- Bachelor's degree in Engineering, Biotechnology, Life Sciences or a related field.
- 7+ years of QA production experience in the medical device industry.
- In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971 and EU MDR.
- Hands-on experience with ECOs, nonconformance management, CAPA and root cause analysis tools.
- Strong written and spoken English.
- Preferred: knowledge of Lean, Six Sigma or continuous improvement methods, and ability to work in a fast-paced, cross-functional manufacturing environment.
What we offer
- A competitive salary and a flexible benefits package.
- Eligibility for the Medtronic Incentive Plan (MIP), a short-term incentive.
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medtronic
Yoqneam Illit
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