Job Description

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Define, plan, direct, lead, and perform Quality and Compliance organization and activities concerned with the development, application, compliance, maintenance, and improvement of the quality management system, within a manufacturing and product development environment, in accordance with the applicable FDA, ISO, and AATB Quality System, Medical Device, and Human Tissue regulatory standards and practices.

Principal Duties and Responsibilities

Management Representative for facility Lead interface and responsible for Regulatory Body and Industry Audits CAPA/Non-Conforming material Internal Audits Supplier Quality Complaint Analysis and file support Procedure generation / Document / Records Manage Change Control and Training Admin/program Sterilization Program Validation Program: Equipment, Process and Design Design Review/Risk Analysis Support Test Procedure Development and Execution Manage Inspection and Test resources Regulatory Affairs Support Calibration/Preventive Maintenance Tissue Compliance/Registrations/Tracking System Donor File Approval Coordination and C of C Support Support various ZB Business and Distribution activities and sites

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.

Expected Areas of Competence

Lead and motivate team members through feedback and stretch assignments. Establishes and maintains high levels of credibility. Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results. Interpret engineering drawings and specifications. Teamwork and customer focus oriented. Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people. Must possess good writing skills and be familiar with both the scientific and vernacular vocabularies. Good knowledge of applicable government specifications, standards and regulations such as Quality System Regulation and ISO standards.

Education/Experience Requirements

This position requires a Bachelors Degree preferably in engineering or a related discipline with 6-8 years of work experience in quality functions, or an advanced degree (ex. Masters) in a related discipline Tissue: AATB and 1271 Aseptic Assembly/Processing/Environmental/Controls Gamma Sterilization Regulatory Affairs/Compliance Biologics Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.). Must be experienced in all aspects of modern quality control methods such as nondestructive testing, metrology, statistical process control, quality cost accounting, applied statistics and inspection. Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies. Quality Engineering Certification (ASQ) a plus.

Travel Requirements

Up to 10%

Additional Information

EOE/M/W/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.