URGENT Supplier QA Engineer -Swiss MedTech - German/English
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Description
Supplier Quality Engineer -Swiss MedTech - German/English essential
Today I am looking for a Supplier Quality Engineer for our client, a well known Swiss Medical Devices manufacturer with an international well financed parent, and located just outside of Zurich. The position will be around 9 months, ideally to start ASAP, and with a focus on resolving Supplier issues and closing non conformances, while generally supporting the QA department.
Essential criteria for this role are
- 4+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485
- Auditing experience to ISO 13485
- English essential, German beneficial
- Ideally also exposure/experience in labelling issues
Key Responsibilities:
- Ensure suppliers deliver quality parts, materials, and services, resolving supplier-related problems using the corrective/preventative action process. Institute appropriate root cause corrective actions relating to customer complaints and production defects
- Participate in the audit/assessment of suppliers, ensuring compliance with medical device regulatory guidelines (GMP, FDA, ISO13485)
- Review and approval of supplier process validations
- Ensure maintenance of supplier-related technical documentation, update QMS documents
- Support to Inspection of incoming and outgoing goods including labelling
- Support of complaint processing including vigilance re-porting and trending.
- Support operations with maintaining & improving specifications, inspection methods, protocols and instructions
For more information on this vacancy, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and work references.
Keywords: Supplier Quality, Compliance, labelling, manufacturing, Quality Management, complaints handling, CAPA, non conformance, deviation, MDD, MDR, ISO 13485, GMP, FDA, inspection, audit, supply chain, engineering, technical, supplier agreement, Medical devices, Switzerland, English, German, NonStop Consulting
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