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 talent 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 included, respected, empowered and recognised. **What You Can Expect** **Job Summary** The position is responsible for leading the global development, implementation, and continuous improvement of the Supplier Quality Management System (SQMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and EU MDR. This role drives strategic quality initiatives across the enterprise, ensuring consistent and robust supplier oversight, risk mitigation, and regulatory compliance across the global supply chain. The Quality Systems Project Manager will lead cross-functional, cross-site teams to align and execute supplier quality strategies, support corporate and regulatory audits, and deliver system-level improvements. This position plays a key role in ensuring supplier performance and system effectiveness through proactive governance, data-driven decision-making, and alignment with the company’s global quality objectives. **How You'll Create Impact** **Principal Duties and Responsibilities:** Lead the development and implementation of global supplier quality systems processes and governance models to ensure compliance with global medical device regulations (e.g., FDA QSR, ISO 13485, EU MDR). Collaborate with executive and senior management to establish and execute strategic goals related to supplier quality and quality system performance. Lead cross-functional, global teams in the harmonization and standardization of supplier quality procedures, tools, and best practices across sites and regions. Direct corporate-level initiatives focused on supplier onboarding, qualification, monitoring, and performance improvement using risk-based approaches. Drive continuous improvement projects focused on increasing efficiency, effectiveness, and compliance of quality systems and supplier quality operations. Identify and resolve complex quality system, product, and process issues using structured problem-solving and root cause analysis methodologies. Lead or support supplier audits, internal quality system audits, and regulatory inspections, including preparation, execution, and response activities. _This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._ **What Makes You Stand Out** **Expected Areas of Competence (i.e., knowledge, skills and abilities)** + Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971. + Strong background in supplier quality management, including supplier selection, qualification, monitoring, and auditing. + Skilled in developing and implementing procedures for purchasing controls, nonconformance management, validation, and corrective and preventive actions (CAPA). + Demonstrated success in leading complex, cross-functional projects in a regulated environment. + Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA). + Strong leadership, communication, and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders. + Experience with enterprise quality systems and ERP systems (e.g., SAP). + Ability to work independently, manage competing priorities, and make data-driven decisions + Must have previous Medical Device Experience **Your Background** **Education/Experience Requirements** + High school diploma or equivalent required. + Bachelor’s degree in Engineering, Business Administration, or Finance preferred + Technical, engineering, and/or scientific background is strongly preferred. + Minimum 7 years of experience in Quality/Regulatory Compliance or related field required + 5 years’ previous experience in Project Management is preferred + CQE or equivalent certification preferred. + Must be familiar with Microsoft Office Suite. **Travel Expectations** Rough estimate of travel to internal site locations around once a month **Salary Expectations:** **$115,000-$140,000** EOE/M/F/Vet/Disability