EU MDR SQ Contract Superviser

Solothurn  ‐ Vor Ort
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Beschreibung

You are an Engineer with working experience in a Medical Device regulated environment? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client, an international pharmaceutical company, is looking for you!

Project Goal: To ensure all product technical file contributions meet new EU MDR requirements. Provide updated contributions to each workstream supporting aspects of the technical file. Reference EU MDR Workstreams for Key deliverables. EU MDR SQ Contract Supervisor will work under the direction of the EU MDR SQ Program Leader.

Duties & Responsibilities:

  • Work with internal Workstream leads to develop project goals, deliverables and plans for execution in 2019 inclusive of the 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)
  • Support update of applicable Supplier Quality Procedures and Work Instructions.
  • Build, recruit, and manage a Supplier Quality team to meet all workstream 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 (Tech File input consolidation/coordination (PFMEA, PRM, MPI) with workstream inputs.
  • Manage schedule adherence for SQ plans across workstreams.
  • Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
  • Cross coordinate Workstream activities/interdependencies with other Workstream Leads.
  • Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities
  • 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.
  • Support the update of supplier related Inspection Criteria as applicable.
  • Other related tasks may be assigned at the discretion of local Supplier Quality Management and/or the EU MDR Supply Chain Workstream Core Team (SQ Lead).

Your Profile:

  • A minimum of a Bachelor's degree or equivalent in Engineering and/or Technical Field is required.
  • A minimum of 3 years' experience in a supervisory capacity is required.
  • 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. Excellent organizational skills and attention to detail is required.
  • Must be able to work independently and prioritize with limited supervision.
  • Strong written and oral communication and interpersonal (listening) skills.
  • Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you.

Start
keine Angabe
Von
Harvey Nash IT Recruitment Switzerland
Eingestellt
14.11.2018
Projekt-ID:
1666274
Vertragsart
Freiberuflich
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