A growing industry leader producing orthopedic implants and surgical instruments is searching for a quality professional to support their world class manufacturing operation. This is a great opportunity for Quality Engineers in the medical device industry or other highly regulated industries. We will consider candidates in the highly regulated aerospace, nuclear, defense and/or automotive industry with quality engineering and experience working in a machining environment. The Quality Engineer will need good Gd&T skills and the ability to develop inspection plans, work instructions, specify inspection tools, calibrate gauges and train others in statistical methods, process controls and validations. Past experience developing FMEA, control plans, work instructions, process flow diagrams, as well as, conducting first articles and gauge R&R. Interested candidates will needed experience using measuring equipment, and developing raw material, in-process and final inspection plans. Strong statistical experience and the ability to develop SPC criteria and analyze SPC data is needed. The Quality Engineer will maintain master records and part history records. Knowledge of internal and external auditing is a plus. Candidates will need the ability to communicate and train others in SPC methodology, inspection processes and use of measuring equipment. Past experience working in the medical industry is preferred, however, not required. The focus of this position is to develop the process controls, methodology and inspection criteria of close tolerance machined components. Strong problem solving skills and the ability to ensure quality products are being manufactured if needed. Product launch experience is a plus.
MUST HAVE: 5 plus years of experience in Quality Engineering in a machining environment and solid metrology skills. Candidates with experience in highly regulated industries such as medical, aerospace, nuclear, defense and/or automotive should apply.
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