CAPA Specialist

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.

• 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 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.

• 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.

• Independently coordinate and/or assist with CAPA processes as assigned, including scheduling meetings, tracking workflow, ensuring tasks are completed in a timely manner, records and evidence are saved.
• 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.

• 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 should not exceed 10% of total time. Supplier travel might be needed for on‑site troubleshooting and/or audits.

Salary Range: $60, USD Annually, depending on skills and experience.

EOE/M/F/Vet/Disability