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Home Based Capa Manager Jobs in Utah (NOW HIRING)

Varex Imaging

CAPA Process Lead

Salt Lake City, UT · On-site

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.

Vareximaging

CAPA Process Lead

Salt Lake City, UT · On-site

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.

Eduro Healthcare

Mobile Outpatient PTA

Salt Lake City, UT · On-site

$32 - $35/hr

Professional Growth Gain expertise in outpatient geriatric therapy, community-based care delivery, functional mobility, home safety, and chronic condition management. Variety Every Day Move through ...

Better Butter

Food Safety Manager

Salt Lake City, UT · On-site

$110K - $140K/yr

Director of Operations Pay: $110K-$140K, based on experience. Job Summary: We are seeking an ... Experience conducting root cause investigations and implementing CAPA programs. Excellent ...

BetterButter

Food Safety Manager

Salt Lake City, UT · On-site

$110K - $140K/yr

Director of Operations Pay: $110K-$140K, based on experience. Job Summary: We are seeking an ... CAPA). • Monitor key quality metrics and drive continuous improvement initiatives to reduce non ...

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Home Based Capa Manager information

What is the difference between Home Based Capa Manager vs Home Based Quality Assurance Specialist?

AspectHome Based Capa ManagerHome Based Quality Assurance Specialist
CredentialsTypically requires a degree in life sciences or related field, with certifications in CAPA or quality managementRequires a degree in quality assurance, life sciences, or related, often with certifications like CQE or ISO auditor
Work EnvironmentPrimarily remote, overseeing CAPA processes within pharmaceutical or biotech companiesPrimarily remote, focusing on quality systems, audits, and compliance in similar industries
Employer & IndustryPharmaceutical, biotech, medical device companiesPharmaceutical, biotech, medical device companies

The main difference is that a Home Based Capa Manager focuses on managing Corrective and Preventive Actions to address quality issues, while a Home Based Quality Assurance Specialist concentrates on maintaining quality systems and compliance. Both roles are essential in ensuring product safety and efficacy but differ in their specific responsibilities and focus areas.

What are popular job titles related to Home Based Capa Manager jobs in Utah? For Home Based Capa Manager jobs in Utah, the most frequently searched job titles are:
What job categories do people searching Home Based Capa Manager jobs in Utah look for? The top searched job categories for Home Based Capa Manager jobs in Utah are:
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Home Based Capa Manager jobs near you

CAPA Process Lead

Varex Imaging

Salt Lake City, UT • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 23 days ago

Varex Imaging rating

7.3

Company rating: 7.3 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

102nd of 157 rated electronics manufacturers

Job description

To apply to a Varex Imaging position, please create an account and sign-in.
CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.
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.

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