QA Manager - Medical Markets: Looking for a Quality Manager with a high focus on medical.
Skills Set should include:
Knowledge in 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.
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.
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.
Strong Computer skills ? MS Office programs (Word, Excel, Powerpoint); Bias to data analysis and Excel pivot table experience required.
Excellent communication skills; Positive influence in working with others cooperatively under stressful situations.
A plus would be knowledge & understanding of plastic injection molded parts and related inspection activities.
Additional Salary Information: Salary will be commensurate to education and background knowledge.
Seitz is a solutions provider and has been manufacturing injection molded drivetrain components and assembled systems for over 60 years. We are known throughout the marketplace for our gear design expertise, quick tooling capability, quality molded products, manufactured sub-assemblies and assemblies. Seitz Injection Molded Gears of all design types including miniature sizes and miscellaneous co...mponents up through large chassis and clear cosmetic parts with insert molding, over-molding, two-shot molding and secondary operations are all commonplace in our 88,000 Sq. Ft Connecticut facility and in our 55,000 Sq. Ft. Changzhou China facility. Seitz Assembled Products – With our drivetrain at the core, we developed and produce products such as actuators, gear motors and gear pumps. We also assemble many other products for the broad markets we serve.