Manufacturing Engineer-Urgent

Manufacturing Engineer-Urgent

Location: Mounds View, MN

Need candidate from Medical domain side, Electrical engineering degree mandatory

Keywords: Risk assessment, Labeling, TMV, Production control, CAPA, DFMEA, PFMEA, IQ/OQ/PQ, QSR 21 CFR 820, ISO 13485, ISO 14971, Track wise

Job Description

1. Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA))
2. Good experience in CAPA process.
3. Measurement System Analysis / Test method Validation
4. Test protocol and report preparation
5. Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
6. Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan
7. Route PPAP Checklist in Agile
8. Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.
9. PPAP experience
10. Supplier document review and approve per MDT process
11. Supplier control and management
12. Work closely with supplier
13. Track wise and MAP agile experience
14. Critical component identification and qualification
15. Perform receiving inspection
16. Driving supplier activities
17. Leadership toward supplier activities and interaction