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Warsaw, IN

Document Control Supervisor (689639)

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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.

Under minimal supervision, Maintain Document Control program to ensure compliance to domestic and international medical device regulations.
Principal Duties and Responsibilities
Coordinate department in creation of Device Master Records such as Part Data packets, part numbers, Router's, and BOM's within ERP system. Coordinate creation of new part numbers within ERP software for design teams and Marketing department. Coordinate the archival of Device Master Records and Device History Records to demonstrate compliance to GMP, ISO, CMDR, and MDD regulations. Manage Change Control program and coordinate department efforts in processing procedural changes via ECO/SCO/LCO as well as distribution of procedures to needed areas. Manage the company intranet to ensure adequate distribution of procedures and that quality system documentation is available at all points of use. Assist department efforts in audits, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and MDD regulations. Manage the review, approval and distribution of product labeling and instructions for use intended for domestic and international distribution. Coordinate the creation and maintenance of various databases and procedures for the department.
Expected Areas of Competence
* Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices. * Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship * Proficiency in report writing * Good word processing and data base skills * Outstanding organizational skills * High attention to detail.
Education/Experience Requirements
* Bachelor's Degree in life sciences field or equivalent with a minimum of 5 years relevant work experience.
Travel Requirements
Mininmal
Additional Information
EOE M/F/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.

Job ID: 1100780021495846199