Warsaw, IN, 46582, USA
69 days ago
Senior Quality Engineer I
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging. **Duties** The Senior Quality Engineer I will assure products conform to established requirements and standards through appropriate audit, inspection, and test activities; gather relevant, factual information and data in order to solve quality related problems; resolve issues by identifying and applying solutions from acquired technical experience and guided precedents; plan and lead quality engineering projects by identifying and organizing activities into time dependent sequencing with realistic timelines, from concept through design, implementation, testing, documentation, support, and maintenance; interact with different functional departments, suppliers, and experts to implement quality goals; develop and implement corrective/preventative action plans; review and analyze product complaints through investigation to determine a definitive root cause; support regulatory audits with backroom activities such as pulling and reviewing quality documents; support product trending activities and meetings to assist cross-functional teams with review or rationalization of product triggers. **Requirements - Education and Experience** Requires a bachelor's degree in mechanical engineering or related engineering field or foreign equivalent. Requires 3 years of experience in a Quality Engineering role. Must have 3 years of experience with the following: FDA regulated industry experience with extensive knowledge of FDA 21 CFR Part 820, Part 803 and Part 806, IS013485, and IS014971; Microsoft Office Suite, blueprint reading and geometric dimensioning and tolerancing; QSR/ISO regulations, design assurance, FMEA, and product testing methods. Must have 2 years of with the following: Six Sigma project experience; technical audience; problem solving through use of quality and statistical tools. **Travel Expectations** 100% on site - Up to 20% of domestic travel required. **LOCATION** : Biomet Manufacturing, LLC (formerly Corp.), 56 E Bell Drive, Warsaw, IN 46582 EOE/M/F/Vet/Disability
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