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Summary
The CAPA Process Lead is an experienced individual contributor responsible for the effective execution, governance, and continual improvement of Varex's global Corrective and Preventive Action (CAPA) process. This role facilitates complex CAPA activities from issue identification through investigation, root cause determination, action implementation, effectiveness verification, and closure. Working across functions and sites, the CAPA Process Lead provides subject-matter expertise, coaching, analytics, and audit-ready documentation to ensure CAPAs are timely, risk-based, sustainable, and compliant with applicable medical device quality system requirements. This position has no direct reports and succeeds through technical leadership, influence, and disciplined follow-through in a fast-paced, matrixed environment.
Job Description
- Serve as the global CAPA process subject-matter expert and lead CAPA records from initiation through approved closure in accordance with established procedures and regulatory requirements.
- Facilitate cross-functional investigations involving product, process, supplier, audit, complaint, nonconformance, and quality system issues; ensure problem statements, scope, containment, and risk assessments are complete and evidence-based.
- Guide teams in the appropriate use of root cause and problem-solving methods, including 5 Whys, fishbone analysis, fault tree analysis, 8D, DMAIC, and statistical techniques.
- Challenge assumptions and assess objective evidence to confirm that identified root causes are supported, corrective and preventive actions address the causes, and actions do not create unintended risks.
- Establish clear deliverables, owners, due dates, and escalation paths; monitor progress and proactively address overdue, stalled, or high-risk CAPAs.
- Define and review effectiveness verification plans with measurable acceptance criteria, appropriate monitoring periods, and statistically or scientifically sound sampling where applicable.
- Review CAPA records for technical quality, completeness, traceability, consistency, and readiness for management, notified body, and regulatory review.
- Prepare and present CAPA status, aging, recurrence, effectiveness, and trend metrics to CAPA Review Boards and management; recommend escalation or systemic improvement actions based on data.
- Provide coaching and practical training to CAPA owners, investigators, and cross-functional teams on investigation rigor, root cause analysis, action planning, effectiveness verification, and documentation expectations.
- Support internal and external audits and regulatory inspections by explaining the CAPA process, retrieving supporting evidence, and coordinating timely responses to observations related to CAPA.
- Identify opportunities to improve CAPA procedures, workflows, templates, system controls, metrics, and training while preserving compliance and data integrity.
- Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, Supplier Quality, Complaint Handling, Service, and other functions to ensure CAPA inputs and related quality records are appropriately linked and addressed.
- Perform other duties consistent with the scope of the CAPA Process Lead role and contribute to a collaborative, respectful, transparent, ethical, efficient, and high-achieving culture.
Minimum Qualifications
- Bachelor's degree in engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of education and relevant experience.
- At least five years of quality assurance, quality engineering, or quality systems experience in the medical device industry, including direct hands-on responsibility for CAPA investigations and records.
- Demonstrated experience leading complex investigations, facilitating root cause analysis, developing risk-based action plans, and verifying effectiveness.
- Working knowledge of FDA Quality Management System Regulation requirements, ISO 13485, ISO 14971, and other applicable medical device quality system requirements.
- Proficiency with structured problem-solving tools and the interpretation of quality data, trends, and basic statistical analyses.
- Strong technical writing, facilitation, project coordination, communication, and influencing skills, with the ability to drive results without direct authority.
- Ability to manage multiple priorities, exercise sound judgment, maintain attention to detail, and escalate compliance or business risks appropriately.
- Preferred Qualifications
- ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma Green Belt or Black Belt, or comparable certification.
- Experience with electronic quality management systems and multi-site or global CAPA governance.
- Experience supporting FDA, notified body, MDSAP, or other regulatory inspections and audits.
Time Type:
Full time
Job Type:
Regular
Work Shift:
First Shift
Pay Rate Type:
Salary
Benefits and Perks
Varex Imaging provides competitive pay and benefits to support the financial, physical, and emotional well-being of the people who make our company successful.
Medical Insurance
Dental/Vision
10 Paid Holidays
PTO
Employee Stock Purchase Plan
401K match
Paid Parental Leave
Short & Long-Term Disability and Life Insurance
Competitive Pay
Flexible Schedules
Variety of Shift Options
Free Safety Shoes
Friendly Work Environment
On-site Cafeteria, Company Nurse, Credit Union, and Gym
Free Coffee and Soda
Tuition Reimbursement
Employee Referral Program
Career Advancement Opportunities
Employee Discounts
EV Charging Stations
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.