CAPA Process Lead

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• 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

• Bachelors 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.

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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.