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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
- Bachelors 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