Global CAPA Process Lead – Quality & Compliance

Varex Imaging Corporation

Salt Lake City (UT)

On-site

USD 100,000 - 135,000

Full time

14 days+

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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.