Job details
Staff Specialist, CAPA (Corrective and Preventive Actions)
Irvine, CA
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.
What You Will Do
- Oversee the end-to-end NC/CAPA process to ensure compliance, completeness, accuracy, effectiveness, and on‑time closure against site/global KPIs.
- Review and approve NC/CAPA records, documentation updates, and extension requests with audit-ready rigor.
- Facilitate cross-functional teams through all NC/CAPA stages using structured problem-solving (e.g., root cause analysis, human error reduction) to prevent recurrence.
- Serve as process owner and subject-matter expert; maintain procedures, contribute to global standards, and act as electronic CAPA system super-user.
- Develop and deliver training for all users; coach new users and specialists; track training effectiveness and close gaps.
- Monitor and report site NC/CAPA metrics; prepare materials for quality/business reviews; drive actions to meet global requirements.
- Lead NC/CAPA Review Board forums and coordinate preparation, participation, and follow-up for internal, corporate, and third‑party audits.
- Identify and lead continuous improvement and cross-site projects to enhance data quality, reporting, and process performance.
What You Will Need
Required
- Bachelor’s Degree in Engineering, Science, or a related field.
- 4+ years of experience in quality or regulatory affairs in a regulated industry (medical device preferred).
Preferred
- Experience with ISO 13485, MDSAP, and 21 CFR 820.
- Experience preparing for and supporting internal, corporate, and third‑party audits.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
- Experience leading site-level NC/CAPA forums and managing NC/CAPA KPIs and dashboards.
- Experience with electronic quality systems (e.g., CAPA/eQMS platforms).
$83,300.00 - $180,400.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
