Supplier Quality Engineer
Posted on Mar 16, 2021 by Michael Bailey Associates - UK Contracts
Title: Supplier Quality Engineer
Project Goal: To ensure all externally manufactured client products meet new EU MDR requirements.
* Become a working member of the technical file remediation efforts to ensure externally manufactured client products meet EU MDR requirements. This includes supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
* Assess supplier drawings and process information to support project deliverables:
o Manufacturing Process Information and Controls
o Production risk management file
o Validation protocols and reports
o Direct part marking documentation
* Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
* Cross coordinate Workstream activities/interdependencies with other workstream and project teams.
* Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;
* 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.
Education & Requirements:
- A minimum of a bachelor's degree or equivalent in engineering or associated technical field is required.
- A minimum of 3 years' experience in a quality engineering is required.
- A minimum of 2 years' experience in the 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.
- FLUENT ENGLISH, GERMAN AN ADVANTAGE
Experience & Knowledge Preferred:
* Three years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.
* Understanding supplier management and validation procedures and execution.
* Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
* Experience working with suppliers across multiple sites and franchises.
* Ability to act as an SME in supplier business processes.
* Experience with medical device technical files.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.