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Associate Quality Engineer-Compliance

Paragon 28, Inc.
Posted 2 days ago, valid for 11 days
Location

Englewood, CO, US

Salary

$50,000 - $70,000 per year

Contract type

Full Time

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Sonic Summary

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  • Zimmer Biomet is seeking an Associate Quality Engineer – CAPA to join their team in Englewood, Colorado.
  • The role focuses on supporting quality initiatives, ensuring compliance with regulatory requirements, and managing Corrective and Preventive Actions (CAPA).
  • Candidates must possess a Bachelor's degree in Engineering or a related technical discipline and have 0 to 2 years of relevant experience.
  • The position offers a salary range of $50,000 to $70,000 USD annually and requires at least three days per week onsite work.
  • Experience in regulated industries and familiarity with standards such as 21 CFR 820/ISO13485 are preferred.

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

Paragon 28, a Zimmer Biomet company based in Englewood, Colorado, is dedicated to advancing innovative orthopedic medical device solutions for the foot and ankle. We’re looking for an Associate Quality Engineer – CAPA to join our Colorado team. In this role, you’ll support Quality initiatives by helping ensure compliance with regulatory requirements, industry standards, and our Quality Management System, with a focus on Corrective and Preventive Actions (CAPA). This hybrid position requires at least three days per week onsite at our Englewood, CO location.

How You'll Create Impact

  • Manage CAPAs/SCARs , including collection of all required data, in compliance with established standards and timelines.
  • Assist in complaint handling activities including device investigations. 
  • Organize and maintain departmental records in accordance with documented procedures and/or requirements. 
  • Calculate metrics and prepare reports as requested. 
  • Other duties as assigned.

Your Background

  • Bachelor’s degree in Engineering or technical discipline 
  • 0 - 2 years of related experience.
  • Experience in regulated industries.
  • Strong computer skills (MS Office Suite and Adobe).
  • Ability and desire to learn quickly and work with minimal supervision
  • Medical device experience preferred.
  • Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards preferred.

Compensation Data

Salary Range $50,000 - $70,000 USD annually


EOE/M/F/Vet/Disability




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