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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
Under minimal supervision, Maintain Document Control program to ensure compliance to domestic and international medical device regulations.
How You'll Create Impact
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Manage Change Control program and coordinate department efforts in processing Quality System change orders. Provide direction and support to Change Analysts.
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Provide leadership to team members in order to support training process and Master Data Management system (SAP).
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Provide support to site LMS Administrators.
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Support standardizing and harmonizing document control processes across sites where applicable.
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Develop and maintain document control procedures and work instructions.
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Provide training on document control system to familiarize users with system. Provide training to new team members.
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Support site assessment process to ensure compliance to external standards and regulations where applicable.
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Develop and execute process improvements when necessary to ensure the Document Control process meets users’ needs and requirements.
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Provide local administrator support for implementation and use of integrated electronic document management system.
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Organize and develop an integrated classification and storage system to facilitate access to Quality records including DHRs.
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Coordinate project work related to integration of sites and migration to integrated systems.
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Track and report status of projects managed by Document Control.
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Assist department efforts in aduits, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, MDD and MDR regulations.
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
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Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices.
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Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship
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Proficiency in report writing
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Good word processing and data base skills
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Outstanding organizational skill
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High attention to detail.
Your Background
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Bachelor’s Degree in life sciences field or equivalent with 3-5 years relevant work experience.
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Proficient in Enlgish - written and spoken B2.
Travel Expectations
EOE/M/F/Vet/Disability
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