Requirements

Required experience
Between 3 and 5 years
Required language knowledge
English German
Required skills
Compliance supply chain Manufacturing English compliance Supply Chain German COMPLIANCE Supply chain GERMAN gmp FDA german english ISO 13485 Audit CAPA GMP manufacturing GMP Supplier quality German ENGLISH Complaints TECHNICAL audit Non conformance complaints Technical technical MDD Engineering fda MDR MANUFACTURING Audit SUPPLY CHAIN Supplier Quality LABELLING Labelling labelling supplier quality non conformance inspection engineering supplier agreement NonStop Consulting Nonstop Consulting

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
CNC / Machine operator Design / CAD / CAM Quality Control / Processes Management / Project Managemen... Electronics / Electrotechnical Alternative / Renewable energy Environment / Safety Engineer / R & D Mechanic (Precision / Micro /... Car Mechanic / Car Electrician... Preparatory Work / Production Manual Worker / Qualified Manu... After-Sales Service / Maintena... Speciality of Watchmaking Technical-commercial Business- / Requirement Analys... Consulting / Management / Proj... SAP Project Management / Consu... Data Warehouse / Business Inte... Software Development / Softwar... Web Development / Publishing /... ERP (Oracle, Sage, Infor, Micr... Helpdesk / Support / Training Networks / Security / Hardware Database specialist / Architec... SAP Basis / Module Specialist System Technician / - Administ... Testing / Audit / Release Mana...

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

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

NonStop Consulting
Jun 18, 2022

Contact info

NonStop Consulting
Andrew Boroky
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Not available