Supplier Quality Engineer- 11 months contract Switzerland
The project goal is to ensure all product technical file contributions meet new EU MDR requirements.
• 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 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 • 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).
EDUCATION & EXPERIENCE REQUIREMENTS:
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.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.