ZIMMER BIOMET CMF AND THORACIC, LLC – $77,563.00/Year

Requires a Bachelors degree in Engineering or related field and 3 years of experience in Engineering, Quality, Development or related position. Must have 3 years of experience with the following Process validation experience drafting technical protocols IQ, OQ, and PQ for special processes, performing characterization studies and executing process requirements and analyzing process capabilities; and working with external vendors to establish process requirements and parameters aligning with quality and design requirements. Must have 2 years of experience with the following Solid edge or similar CAD software and Minitab; combination of traditionalnontraditional machining processes, laser etching, cleaning, biologic upgrade, packaging and sterilization; FDA and EU regulations including labeling UDI regulations; implementing RD risk management documents IOVV, aFMEA, dFMEA, pFMEA; and communicating technical requirements user needs to product design specifications. Must have 1 year of experience leading and supporting Gage RRs, Corrective Action Preventive Action CAPA and nonconformances investigation.br br Up to 10 travel required.