Program Manager FAMAC Job at ProStaffing

ProStaffing Claremont, NC 28610

Salary Range: $76,600 - $85,000

Position Summary:
Manages the Pharma Medical new product introduction. This position will actively manage compliance with DQ/IQ/OQ/PQ and change control requirements. This position will interface with customers and colleagues at USA and Germany to ensure trouble free launches of new products and changes to existing products. Maintain adherence to requirements ISO 13485 that apply to activities performed.

Essential Functions:
  • Lead the launch of new programs utilizing PPUSA systems within budget
  • Be the recognized program leader at the customer and internally for all issues prior to Customer approval
  • Assist and monitor Risk Management related to FMEA
  • Ensure that the BOM is accurately loaded into the MRP system, and all production items are identified and approved before SOP
  • Utilize change management process to implement changes to BOM after initial loading and SOP
  • Provide sales team with the necessary information to manage within FAMAC requirements & eliminate cost creep
  • Manage tooling & equipment supplier within FAMAC requirements, molds/machines meet quality & cycle time standards, delivered on time & within budget
  • Coordinate with Quality on any corrective actions after SOP, if necessary
Required Education & Experience:
  • Degree in Engineering Discipline
  • 1-3 years program management
  • 3+ years’ experience in Injection Molding
  • Working experience with ISCO 13485, IATF 16949 etc.
  • GMP experience
  • Clean Room Production experience
  • FDA Knowledge preferred
  • Working experience of CAD systems



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