Job Title

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 patientu2019s 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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging. What You Can Expect Paragon 28, a Zimmer Biomet company focused on orthopedic medical device for the foot and ankle, is hiring a Quality Records and Release Coordinator to join our team in Englewood, Colorado. This role is responsible for review, final verification and scanning of Device History Records (DHR) for product release. These records include, but not limited to inspection records, labeling records, packaging records, material certifications, and Certificates of Conformance of finished medical devices. Additionally, this role will perform assigned incoming inspections on received product, primarily allograft and custom devices. This is a 100% onsite position. How You'll Create Impact Final verification of DHR documentation, including inspection records, certifications, purchase orders and engineering prints u00b7 Confirmation of physical product visual conformance with specifications prior to product release u00b7 Issuance of product release notifications u00b7 Product inspection of assigned parts u00b7 Scanning electronic DHR records as well as preparation of physical records/boxes and submit to Document Control to offsite u00b7 On occasion, incumbents may also be asked to do the following: o Support internal and external audits o Support Complaint and Non-Conformance investigations with DHR requests o Other duties as assigned Your Background Associate Degree and minimum of 5 years of experience in medical device inspection/ quality or a Bacheloru2019s degree in technical discipline with 2 years of experience in medical device inspection/ quality. u00b7 Strong understanding of good documentation practices u00b7 Strong organizational skills u00b7 Detailed oriented u00b7 Ability to follow standard operating procedures u00b7 High proficiency in MS Office 365, Adobe Acrobat DC u00b7 Good written and oral communication skills u00b7 Prefer familiarity with 21 CFR 820/ISO13485, or other government/ISO standards u00b7 Experience in Electronic Records Management and/or AIIM training a plus Work Environment This job operates in an office/laboratory environment within a distribution facility. The role routinely uses standard office equipment such as computers, phones, copy machines, and filing cabinets. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee frequently is required to move about the facility. May be required to lift up-to 30 lbs. by themselves. Position Type/Expected Hours of Work This is a full-time, onsite hourly position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined by the supervisor and manager. Travel Expectations No overnight travel is required. EOE