Staff Specialist CAPA

Stryker • Irvine, CA

6d • Onsite

About The Position

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.

Requirements

• 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).

Nice To Haves

• 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).

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees