Quality Release & Records Coordinator

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 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.

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.

• Final verification of DHR documentation, including inspection records, certifications, purchase orders and engineering prints
• Confirmation of physical product visual conformance with specifications prior to product release
• Issuance of product release notifications
• Product inspection of assigned parts
• Scanning electronic DHR records as well as preparation of physical records/boxes and submit to Document Control to offsite

On occasion, incumbents may also be asked to do the following:

• Support internal and external audits
• Support Complaint and Non-Conformance investigations with DHR requests
• Other duties as assigned

Associate Degree and minimum of 5 years of experience in medical device inspection/ quality or a Bachelor’s degree in technical discipline with 2 years of experience in medical device inspection/ quality.

• Strong understanding of good documentation practices
• Strong organizational skills
• Detailed oriented
• Ability to follow standard operating procedures
• High proficiency in MS Office 365, Adobe Acrobat DC
• Good written and oral communication skills
• Prefer familiarity with 21 CFR 820/ISO
  13485, or other government/ISO standards
• Experience in Electronic Records Management and/or AIIM training a plus

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.

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.

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.

No overnight travel is required.

EOE