Supplier 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. What You Can Expect Paragon 28, a Zimmer Biomet company focused on orthopedic medical device for the foot and ankle. The Supplier Quality Engineer is responsible for developing and maintaining Paragon 28's supplier quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 products. How You'll Create Impact Audit suppliers on time and per schedule as a lead auditor or with assistance of a lead auditor. Write audit plans and audit reports for suppliers to all applicable standards and regulations. Participate on project teams as a contributing member by providing supplier quality engineering support in the development of new suppliers and processes, and continuously improving company's products and suppliers. Write and review procedures, plans, protocols and reports to ensure regulatory compliance. Assist in development of measurement techniques for product release at suppliers. Perform Mechanical Inspections and use typical equipment used in inspection. Assist with Design Transfer for release of new product development projects. Author and/or assist in the development and execution of process validations at suppliers Perform statistical analysis for testing requirements and develop MSAs, TMQs, and inspection correlations. Provide support for the manufacturing areas (external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems. Assist suppliers in completion of Supplier Corrective Actions per appropriate timelines. Assisting project teams on compliance with purchasing requirements per FDA QSR, European

MDD/MDR, ISO

13485 and other applicable ISO/EN standards. Participate in risk management activities in compliance with

ISO 14971

as expressed in the company's Quality Management System. Assist with supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed. Capture and calculate supplier metrics per scorecards on a regular basis. Develop relationships with employees and suppliers to ensure team-oriented operation. Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.). Other duties as assigned. Your Background Bachelor's degree in Engineering or technical discipline 2+ years in related field, preferably medical device. Familiarity with 21 CFR 820 and

ISO 13485

2016 and other Government / ISO Standards Medical Device Supplier & Purchasing Controls Technical writing skills that include Quality Management Systems (QMS) and procedures Proficient in Geometric Dimensioning and Tolerancing (GD&T) preferable Process Validation experience Proficient in Machining methodologies (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers. MDSAP experience preferable Basic Computer Skills (MS Office) Travel Expectations Travel up to 40%. Supplier travel might be needed for on-site trouble shooting and or audits.

Compensation Data Salary Range:

$68,000 - $82,000 depending on skills and experience EOE