CAPA Specialist

What You Can Expect

Champion Quality. Drive Continuous Improvement.

Paragon 28 (a Zimmer Biomet company) is on a mission to redefine foot and ankle orthopedic care. We are looking for a sharp, proactive CAPA Specialist to join our elite Quality Department in Englewood, Colorado.

If you love investigating root causes, solving complex puzzles, and building airtight quality systems that directly protect patient safety, this is your next career move!

Your Impact

• Own the CAPA Lifecycle: Lead investigations from root-cause analysis all the way through to successful implementation and effectiveness verification.
• Drive Audit Excellence: Play a central role in executing, managing, and refining internal and external quality system audits.
• Protect the System: Actively maintain and elevate Paragon 28's quality management system (QMS) to ensure peak compliance and operational excellence.
• Collaborate for Success: Partner with cross-functional teams to turn quality data into actionable, long-term operational improvements.

What You Bring

• Solid experience managing Corrective and Preventive Actions (CAPA) within the medical device industry.
• A strong background in QMS auditing and compliance tracking.
• Exceptional problem-solving skills and a passion for continuous improvement.
• A highly collaborative mindset to help teams solve quality challenges together.

Ready to make a massive impact on global patient mobility from our Englewood headquarters? Apply today!

How You'll Create Impact

• Independently coordinate and/or assist with CAPA processes as assigned. To include scheduling meetings, tracking workflow, ensuring tasks are completed in a timely manner, records and evidence are saved as appropriate, etc. 
• Actively participate in CAPA meetings; accurately capture minutes of meetings to include status, next steps and needs to accommodate CAPA closure. 
• Review CAPA records and evidence to ensure compliance to QMS procedures. 
• Support monthly efforts on metrics associated with CAPAs and the Quality Compliance Department.
• Ensure continued compliance of work to QMS requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards. 
• Develop relationships with employees to ensure team-oriented operation.
• Other duties as assigned.

Your Background

• Bachelor’s degree preferred with 2+ years of related experience, preferably in medical device; a combination of education and experience will be considered. 
• Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards and/or regulated environments. 
• Basic Computer Skills (MS Office)

Travel Expectations

Travel should not exceed 10% of total time.  Supplier travel might be needed for on-site trouble shooting and or audits

Compensation Data

Salary Range:  $60,000-75,000 USD Annually depending on skills and experience