- Medical customer and ISO13485 process development, audit management, and registration.
- IQOQPQ Process Management; Protocol development, compliance/fulfillment, documentation development and submittal.
- Develop quality plans, inspection processes and control plans for medical customers’ projects
- Participate in Product and Process Design and Development for medical customers.
- Interface with medical customers’ quality organizations on PPAP deliverables.
- Within scope of products for medical customers, respond to abnormalities, quickly resolve issues and accelerate problem solving.
- Participate in Material Review Board (MRB) for products for medical customers.
- Address abnormalites to quickly resolve issues that will impact delivery.
- Promote and ensure compliance with all company policies and Quality Management System requirements.
- BS degree in Engineering (or related discipline) preferred with 7+/- years’ experience in quality systems in a manufacturing setting.
- A hands-on, progressive, assertive leader, with a fast pace, high stamina and “Whatever it takes” attitude. Self-motivated, able to work and complete tasks timely with minimal supervision and work well under pressure.
- Experience & ability to implement and improve organizational compliance with quality systems.
- Working knowledge and proficiency with statistics, SPC, Gauge R&R, metrology, hand held and programmable gauges, CMMs and inspection methods linked to ANSI Y14.5 and Geometric
- Excellent people skills & leadership, management of direct reports, customer presence, negotiation, conflict resolution
- Thorough knowledge of molding and assembly equipment, processes, and procedures. Understanding of plastic injection parts and molds, injection molding and related inspection/quality documentation processes.
- Strong Computer skills ‑ MS Office programs (Word, Excel, Powerpoint); Bias to data analysis and Excel pivot table experience required.