I'm supporting a large Medical Device client in the Greater Philadelphia area to secure a Supplier Quality Engineer for a 2 year EU MDR project. This will be a 100% on site role.
This position is paying from $50-$70 an hour (all-inclusive) depending on experience and interviews are commencing on 18th & 19th February.
- Ensure externally manufactured 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:
- Manufacturing Process Information
- Production risk management file
- Validation protocols and reports
- 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.
Knowledge and experience required:
- 3+ years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within the Medical Device industry
- Understanding supplier management and validation procedures and execution.
- Experience working with suppliers across multiple sites and franchises.
- Ability to act as an SME in supplier business processes.
**NO SPONSORSHIP** **W2 ONLY***
Sthree US is acting as an Employment Business in relation to this vacancy.