Zimmer Biomet is a global medical technology leader. 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.
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
• 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:
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 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/ISO13485, or other government/ISO standards
• 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
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
• 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:
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 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/ISO13485, or other government/ISO standards
• 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