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System Quality Supervisor - European Medical Device Regulation

  • Salary: CHF70 - CHF75 per hour
  • Job type: Contract, Full-time
  • Location: Zuchwil, Lucerne
  • Sector: Pharma & Life Sciences
  • Date posted: 26/09/2018
  • Job reference: BBBH88986
This vacancy has now expired.

Experis recognizes you are more than just a CV, a job title or job description. We'll work with you to understand your unique talents, experience and interests to help propel you to your goals faster. Experis will leverage our extensive client network to help you accelerate your career and realize your potential to them.

My client is one of the leading Pharmaceutical companies in Switzerland and is looking for a EU MDR SQ Contract Supervisor for his project which is launching at the beginning of October. This is a contract in Zuchwil (Luzern). If you are interested in the position, then please check the criteria below:

Main responsibilities

  • Following Workstreams: Packaging & Labeling / Direct Part Marking / Quality Management Systems / Purchase for Resale / MPI Working Group (Manufacturing Process Development) (MDD) / Biological Safety Requirements / Tech File Remediation (PFMEA, PRM, MPI)
  • Build, recruit, and manage a Supplier Quality team to meet all workstream objectives
  • Manage SQ (system quality) resources to bring Technical Files into compliance with new EU Medical Device Regulations as well as re-registering
  • Manage schedule adherence for SQ plans across workstreams
  • Support definition and clarification of EU MDR supplier related process requirements
  • Support, review and approve supplier's Process Validation Protocols and Reports
  • Partner with the Supply Chain Workstream Core Team to meet project deadlines

Requirements

  • Bachelor`s degree or equivalent in Engineering and/or Technical Field
  • At least 3 years of experience working as a supervisor
  • A minimum of 2 years of experience in a medical device and/or pharmaceutical industry
  • Familiarity with ISO-13485 and FDA QSR is required. Excellent organizational skills and attention to detail is required
  • Able to work independently and prioritize with limited supervision
  • Proficiency in Microsoft Office suite

Nice to have

  • Three years of experience as Project Engineer, Quality Engineer, Project Manager or equivalent role within a highly-regulated industry
  • Background in Supplier Management and Process Validation / Verification
  • Process Excellence Black Belt or Master Black Belt
  • Ability to coach and guide core team on project expectations and track progress across multiple-sites and projects

General Information

Start Date: 01.10.2018

End Date: 30.09.2019

Location: Zuchwil, Lucerne

Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Virginia Belli Colon on +41 61 282 22 10

Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.

Check out all of Experis' jobs at www.experis.ch or visit my personal page https://www.experis.ch/virginia-belli-colon and connect to me on www.linkedin.com/in/virginiabelli/

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