"Alerted.org

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

Site Quality leader and Management Representative responsible for directing the quality function a medical device design and manufacturing site. Utilizes quality statistics to develop effective strategies to maintain and improve the performance of products and the quality system. Develops relationships with key development and manufacturing peers to identify emerging needs. Resolves complex problems that have implications beyond own area. Requires professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines and business units. Takes accountability, achieves results and develops self and others.

How You'll Create Impact

+ Develop and implement site-wide quality strategy aligned with corporate objectives and regulatory requirements (QMSR, GMP, ISO, and other global standards) including objectives, and planning to support the strategy.

+ Establish and refine key quality metrics, ensuring data-driven decision-making to enhance product integrity and regulatory compliance.

+ Partner with R&D, supply chain, manufacturing, and distribution teams to enhance quality processes across the product lifecycle and drive cross-functional teamwork to improve operational efficiencies, ensuring seamless integration of quality in all aspects of pharmaceutical production.

+ Serve as the primary quality representative during regulatory inspections and audits, ensuring adherence to industry and corporate standards.

+ Build, mentor, and lead a high-performing quality assurance and quality control (QA/QC) team, fostering a culture of collaboration and accountability.

+ Empower team to lead investigations into deviations, CAPA (Corrective and Preventive Actions), and change control processes to improve operational resilience and ensure timely product release and market supply by resolving quality-related issues effectively

What Makes You Stand Out

+ Must have a thorough knowledge of QMSR, GMP, ISO and other relevant regulatory requirements as applied to medical device development, manufacturing and distribution.

+ Demonstrated independent decision-making ability applying regulations and standards related to the manufacturing and distribution of medical device products.

+ Demonstrated management ability including organizational design and employee selection, development, motivation and performance.

+ Demonstrated ability to achieve productivity goals collaboratively without sacrificing quality in a manufacturing environment.

+ Demonstrated understanding of interactions and interdependency of elements within the quality system in a pharmaceutical manufacturing organization.

+ Must be able to work with all levels of employees, including hourly production employees through senior management.

+ Must possess excellent written and oral communication skills and the demonstrated ability to communicate with individuals of varying backgrounds.

Your Background

+ A Bachelor’s Degree in a technical field is required

+ 7-10 years of work experience in medical device quality, preferably in manufacturing environments

+ 5 years’ experience with direct management responsibility

+ CQE/CQM preferred

EOE/M/F/Vet/Disability