Position Name Technical Lead

Type of hiring 12 Months + (Contract)

W2 or C2C

Location Mounds View , Minnesota - Onsite

Job Description:

Keywords : PPAP, DFMEA, PFMEA, IQ/OQ/PQ, Mini tap, QSR 21 CFR 820, ISO 13485, ISO 14971

1. Ensure that suppliers deliver quality parts, materials, and services.

2. Qualify suppliers according to company standards.

3. Review and approve the documents required to qualify through PPAP process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)

4. Supplier risk segmentation.

5. Supplier Quality Agreements.

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

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

8. Route PPAP Checklist in Agile

9. 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.

10. Measurement System Analysis / Test method Validation

11. PPAP experience

12. Supplier document review and approve per MDT process

13. Supplier control and management

14. Work closely with supplier

15. Mini tap experience

16. Critical component identification and qualification

17. Perform receiving inspection

18. Driving supplier activities

19. Leadership toward supplier activities and interaction

Thanks &