Staff Specialist CAPA

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.