Supplier Quality Contract Supervisor

Proclinical is currently recruiting for a Supplier Quality Contract Supervisor to be contract based at our client's site in Bern, Switzerland.

This Engineering role will have to ensure all product technical file contributions meet new EU MDR requirements. Provide updated contributions to each work stream supporting aspects of the technical file. Reference EU MDR Work streams for Key deliverable. EU MDR SQ Contract Supervisor will work under the direction of the EU MDR SQ Program Leader.
EU MDR SQ Contract Supervisor has primary responsibility to lead the EU MDR program Supplier Quality organisation in the (US or EU) and reports directly to the EU MDR SQ Program Lead. EU MDR SQ Contract Supervisor will liaise work stream leads to shape project goals, deliverable and plans for execution in 2019 and will build, recruit, and manage an SQ team in the (US or EU) to meet all work stream objectives.

Job Responsibilties:

• Packaging & Labelling
• Direct Part Marking
• Quality Management Systems
• Purchase for Resale
• MPI Working Group (Manufacturing Process Development)
• Biological Safety Requirements
• Tech File Remediation (PFMEA, PRM, MPI)
• Support update of applicable Supplier Quality Procedures and Work Instructions.
• Build, recruit, and manage a Supplier Quality team to meet all work stream objectives.
• Manage SQ resources to bring Technical Files into compliance with new EU Medical Device Regulations (EU MDR, formerly known as MDD) and re-registering medical devices in the EU.
• Manage schedule adherence for SQ plans across work streams.
• Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
• Partner with EU MDR Supply Chain Workstream Core Team to support tracking and expediting of supplier related product codes to meet project deadlines
• Support definition and clarification of EU MDR supplier related process requirements.
• Support Review and Approval EU MDR Change Projects as applicable.
• Support Supplier Quality Functional Impact Assessments as applicable.
• Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.

Skills and Requirements:

• Bachelor's degree or equivalent in Engineering and/or Technical Field is required.
• 3 Years of experience as Project Engineer, Quality Engineer, Project Manager or equivalent role within regulated industry.
• A minimum of 2 years of experience in a medical device and/or pharmaceutical industry is required.
• Familiarity with ISO-13485 and FDA QSR is required.
• Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
• Experience with GD&T, Inspection Methods, and Drawing Review/Approval.
• Experience working with suppliers across multiple sites and business centres.
• 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.
• Ability to act as an SME in critical compliance and business processes.
• Excellent computer, communication, and written skills are required.

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sasha Brasero on +44 203 078 9556 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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