Quality Manager

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 ExpectThe Quality Manager has the overall responsibility of developing and maintaining Disior Quality Management System. This role will lead the Disior Quality Management System processes based on the ISO 13485 standard and participate in all phases of the medical software development lifecycle based on IEC 62304 and ISO 14971 standards. The successful candidate will be responsible for ensuring the quality and compliance of Disior medical image analytics software in the European and USA markets, with an aim for global market expansion.How You'll Create ImpactDevelop and maintain the Disior Quality Management SystemOwn the monitoring and reporting activities around the Disior key processes.Monitor and report on Disior's key processes and facilitate management reviews and QMS process risk assessments.Perform internal audits and participate to external audits.Screen external sources for changes in regulations and standard compliance, including product post-market surveillance.Based on the performance metrics, business needs and changes in the requirements, lead updates to the QMS and processes as a continuous improvement.Participate in integration activities of Disior QMS to our parent company Zimmer Biomet. Working as a part of the design team and in close collaboration with the customer-facing teams:Facilitate operating mechanisms to ensure compliance with standard and regulatory requirements of the design.Coach team members to operate according to the quality management system processesParticipate in the regulatory submissions of our medical software products.Develop the Quality culture by driving compliance activities around our medical software family.What Makes You Stand OutExcellent analytical, problem-solving, and root cause analysis skills (e.g., using 5 Whys, Ishikawa).Professional certification such as ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent.Strong leadership and influencing skills with a proven ability to collaborate effectively with cross-functional teams and drive a quality-first culture.Your BackgroundMinimum 5 years professional work experience including 2 years of experience as a Quality Manager within the medical device, software or regulated industries.Direct, hands-on experience managing a QMS compliant with ISO 13485 and FDA 21 CFR Part 820 including CAPA, Non-Conformance handling, Internal/External Audits, Change Control, Design Control, and Risk Management.Proven experience working with the regulatory requirements and standards specific to medical device software (SaMD), such as IEC 62304.Expert-level knowledge of global medical device quality and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR, ISO 14971, IEC 62304).EOE/M/F/Vet/Disability