What are the responsibilities and job description for the Manufacturing Engineer position at TekOne IT Services Pvt. Ltd.?
Job Title : Manufacturing Engineer
Job Duration : Long term
Job Location : Mounds View, MN
- Review and approve production qualification documents (Control Plan, Flow Charts, Process Drawings, Capability Studies, DFMEA, PFMEA).
- Strong experience in CAPA, MSA, and Test Method Validation.
- Prepare and review test protocols and reports.
- Coordinate with suppliers for selection, qualification, and process changes.
- Support and approve Process Validation (IQ / OQ / PQ), MSA, and Control Plans.
- Route PPAP Checklist in Agile and review supplier documents per MDT process.
- Ensure compliance with GMP, FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.
- Supplier control, management, and collaboration.
- Experience with TrackWise, MAP Agile, and PPAP.
- Identify and qualify critical components, perform receiving inspections, and drive supplier activities.
- Provide leadership in supplier interactions and activities.
