What are the responsibilities and job description for the Manufacturing Engineer position at KTek Resourcing?
Manufacturing Engineer
📍 Mounds View, MN | 📄 Long-term Contract
Key Skills: Risk Assessment, Labeling, TMV, Production Control, CAPA, DFMEA, PFMEA, IQ/OQ/PQ, QSR 21 CFR 820, ISO 13485, ISO 14971, TrackWise
🔹 Bachelor’s degree in Electrical Engineering is required.
Job Responsibilities:
✔️ Review & approve production qualification documents (Control Plan, Flow Charts, Drawings, DFMEA, PFMEA)
✔️ Conduct CAPA processes & Test Method Validation (MSA, TMV)
✔️ Develop & review test protocols, reports, and process validations (IQ/OQ/PQ)
✔️ Manage supplier selection, qualification, and compliance
✔️ Route PPAP Checklist in Agile & ensure GMP compliance (FDA QSR, ISO 13485, ISO 14971)
✔️ Drive supplier activities, perform inspections, and oversee critical component qualification
✔️ Utilize TrackWise & MAP Agile for document control and supplier management
