Staff Specialist Capa

Orthopedicjobs

Irvine, CA, US
Base: $83,300.00 - $180,400.00; bonus/equity: bonu...
Onsite
Nc/capa process management
Root cause analysis expertise
Audit-ready compliance
In this role, you will own the nonconformance (NC) and Corrective and Preventive Actions (CAPA) process, driving effective root-cause resolution, sustainable corrective actions, and audit-ready compliance

Job Summary

  • In this role, you will own the nonconformance (NC) and Corrective and Preventive Actions (CAPA) process, driving effective root-cause resolution, sustainable corrective actions, and audit-ready compliance.
  • You’ll shape the future state of our processes, coach teams, and influence outcomes across sites.
  • The position offers a salary range of $83,300.00 - $180,400.00 plus bonus eligibility and benefits.

Matching Summary

In this role, you will own the nonconformance (NC) and Corrective and Preventive Actions (CAPA) process, driving effective root-cause resolution, sustainable corrective actions, and audit-ready compliance.

Salary

Base: $83,300.00 - $180,400.00; Bonus/Equity: Bonus eligible; Benefits: Benefits included

Skills & Requirements

Must-have

  • NC/CAPA process management
  • Root cause analysis expertise
  • Audit-ready compliance
  • Electronic quality systems experience
  • Cross-functional team facilitation

Nice-to-have

  • Training development and delivery
  • Continuous improvement leadership
  • Global standards contribution

Key Requirements

  • Bachelor’s Degree in Engineering or Science
  • 4+ years quality or regulatory affairs experience
  • Experience with ISO 13485, MDSAP, 21 CFR 820
  • Audit preparation and support experience
  • Experience with regulatory agencies interaction

Work Rights

Not specified

Tailored Resume

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