Candidates must have a Bachelor Degree in Mechanical or Manufacturing Engineering with a minimum of 3 + years’ experience as a QA engineer in a medical company working with qualifications of medical product. This candidate will focus on identifying, authoring and executing protocols for defined medical products. A very good understanding and application of Statistics Tools is required. Hands on gaging methods, inspection methods, writing work instructions, processing, fixturing of product and qualifications documentation for FAI’s, Capability Studies, MSA studies, PPAP, PFMEA, Mini-Tab Software and GDT is required. This position will have daily interactions with all levels of engineering from Product Design, Tool Design, Molding, Assembly, Packaging and Quality along with direct Customer interaction on part quality and corrective actions. Experience with ISO 9001 and or ISO 13485 systems is required. Plastic injection molding knowledge is a plus but not necessary. Please send resume along with salary requirements to… [No Recruiters Please]