Job Title: Manufacturing Engineer

Location: Mounds view, MN

Duration: 6+ Month

need candidate from Medical domain side

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

JD

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. 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)

6. Good experience in CAPA process.

7. Measurement System Analysis / Test method Validation

8. Test protocol and report preparation

9. Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.

10. Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan

11. Route PPAP Checklist in Agile

12. 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.

13. PPAP experience

14. Supplier document review and approve per MDT process

15. Supplier control and management

16. Work closely with supplier

17. Track wise and MAP agile experience

18. Critical component identification and qualification

19. Perform receiving inspection

20. Driving supplier activities

21. Leadership toward supplier activities and interaction