CAPA Process Lead

Varex Imaging Corporation; Salt Lake City (UT); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Medical Insurance (Select Health/Regn)

Paid Holidays and Floating Holiday

Paid Time Off

Employee Stock Purchase Plan (15%)

401K Plan through Fidelity

Tuition Reimbursement (up to $7,500)

Disability Insurance (Company Paid)

Life Insurance (Company Paid)

On-site Cafeteria

Nurse on-site

Gym

EV Charging Stations

Secured Parking

Job summary

Varex Imaging Corporation seeks a CAPA Process Lead to govern and continually improve its global CAPA program. You will lead investigations, guide root cause analysis, and implement effective corrective actions across functions and sites in a fast-paced medical device environment.

Responsibilities include coaching teams on problem-solving methods, developing verification plans, and preparing metrics for CAPA reviews.

Qualifications

• Bachelor’s degree in engineering, life sciences, quality, or related technical discipline.
• 5+ years of quality assurance, quality engineering, or quality systems experience in the medical device industry, including direct hands-on responsibility for CAPA investigations.
• 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.

Responsibilities

• Lead CAPA records from initiation through approved closure in accordance with 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.

Skills

CAPA investigations

Root cause analysis

Structured problem-solving

Quality data interpretation

Project coordination

Communication

Technical writing

Influencing without authority

Education

Bachelor’s degree in engineering, life sciences, quality, or related technical discipline

Tools

Electronic quality management systems

Job description

Varex Imaging is a global leading innovator and manufacturer of X-ray imaging products that is expected to grow significantly over the next several years. With more than 75 years of product innovations and numerous global customers that depend on this innovation and manufacturing scale for their success, Varex is well positioned to grow creating a need for strong financial professionals.

CAPA Process Lead

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 Responsibilities

• 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.

Qualifications

• Bachelor’s degree in engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of education and relevant experience.
• 5+ years of quality assurance, quality engineering, or quality systems experience in the medical device industry, including direct hands-on responsibility for CAPA investigations
• 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.

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

BENEFITS Offered to our Employees:

• Medical Insurance (Select Health or Regence)
• 9 Paid Holidays plus 1 Floating Holiday of YOUR Choice
• Paid Time Off
• Employee Stock Purchase Plan (15% Discount)
• 401K Plan through Fidelity
• Tuition Reimbursement (up to $7,500 per Year)
• Short/Long-Term Disability (Company Paid)
• Life Insurance (Company Paid)

Take a Look at Our PERKS:

• ON-SITE Cafeteria, Nurse, Credit Union, and Gym
• Free soda & coffee
• EV Charging Stations
• Secured Parking