New · posted Oct 15
LABONE, LLC., d/b/a Quest Diagnostics · Medical Devices
Specialist, Quality Assurance III (CLS Licensed)
- West Hills, CA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
The Quality Assurance Specialist III is an expert, high-level quality advisor and subject matter expert responsible for the strategic governance of the Quality Management programs, risk management, and regulatory compliance within Quest Diagnostics. This senior-level specialist acts as a quality contact, coordinator for external and internal audits, and regulatory agency inquiries. The QA Specialist III leads root-cause analyses for quality occurrences, works with key individuals to execute root cause analysis, corrective action/preventive action plans (CAPAs) with remediation protocols, conducts system-wide gap analyses, and mentors other QA professionals to cultivate a robust culture of quality, safety, and compliance.
Work Schedule: Hybrid (3 days onsite/ 2 days work from Home)
Strategic Quality Management
- Synthesizes complex quality indicators, audit outcomes, and compliance gaps into high-impact trend analyses and risk matrices.
- Presents summaries and strategic plans to executive committees.
- Governs and approves assigned performance reportables and other non-conformance follow-ups per policy.
Compliance & Audit Management
- Oversees inspection readiness schedules, reviews audits, and leads complex non-conformance audits.
- Primary host/liaison for sponsor audits, partner evaluations, and major regulatory inspections.
- Finalizes and directs Lab Director changes, biennial report approvals, and regulatory submissions.
- Governs PT investigation processes and other laboratory compliance processes as assigned.Oversees inspection readiness schedules, reviews audits, and leads complex non-conformance audits.
- Primary host/liaison for sponsor audits, partner evaluations, and major regulatory inspections.
- Finalizes and directs Lab Director changes, biennial report approvals, and regulatory submissions.
- Governs PT investigation processes and other laboratory compliance processes as assigned.
Continuous Improvement
- Directs, oversees, and finalizes investigations for systemic, critical, or large-scale quality events and RQIs.
- Designs and executes patient-impact reviews, immediate remediation, and long-term CAPAs with effectiveness checks.
- Delivers presentations; trains staff on accreditation-required processes and reviews systemic QI.
Quality Systems Oversight
- System-wide administrator for regional document control software; authors/approves general QA SOPs and rolls out SOPs system-wide.
- Establishes systemic PT oversight, maintains the alternative proficiency testing list, reviews PT folders, and resolves complex inquiries.
- Reviews technical validations/verifications and end-to-end testing.
- Mentors other QA staff; designs QA training curricula and compliance metrics.
- Supports government agency reporting as needed.
What you need
Required Work Experience
8+ years of clinical lab experience, with 3+years in QA/compliance.
Education
Bachelor’s Degree in Medical Technology, Clinical Laboratory Science, Chemical, Physical, or Biological Science from an accredited institution. Must meet CLIA '88 educational requirements for high-complexity testing.
Physical and Mental Requirements
Primarily an office-based position requiring extensive screen time, report generation, and meeting leadership. Ability to walk and stand in laboratory environments during audit processes. Occasional lifting, up to 20 lbs.
Knowledge
- Excellent working knowledge of laboratory regulations and standards (i.e., CMS, CAP, CLIA) and the accreditation processes.
- Strong working proficiency in Laboratory Information Systems (LIS).
- Advanced proficiency in administering enterprise quality systems platforms
- Proficiency in Microsoft Office applications (Word, Excel, Outlook, Teams)
- Detail-oriented.
- Strong organizational and prioritization skills.
- Effective verbal, presentation and interpersonal communication skills; strong writing and composition skills required to draft executive reports and official agency correspondence.
- Ability to track and closely monitor records management.
- Proven leadership and consultation skills; ability to influence, guide, and collaborate effectively with Medical Directors, Lab Executives, and external clients.
- Exceptional project management, analytical, problem-solving, change-management, and relationship-management skills.
- Lean Six Sigma Green Belt training or experience is highly desirable.
- May include people leader responsibilities (Non-Exempt QA Direct reports such as Dept QA Reps)
Licensure
Active California Clinical Laboratory Scientist (CLS) License (Generalist) or a California State Limited License in the applicable specialty is strictly required at the time of hire.
Professional Certification
ASCP (American Society for Clinical Pathology) certification (MLS/MT) or an equivalent national certification is required.
Preferred Work Experiencenice to have
5+ years of dedicated laboratory Quality Assurance experience, showing a progressive trajectory of responsibility and leadership.
What you'll do
Other duties
- Other duties as assigned to meet business needs. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.
- May provide oversight/lead other employees
Pay
$115,000 – $130,000 a year
Employer providedPay Range: $115,000 - $130,000/ year, 5% Bonus
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:
· Medical/Prescription Drugs
· Dental
· Vision
· Flexible Spending Accounts (FSAs)
· Supplemental Health Plans
· 401(k) Plan – Company match dollar-for-dollar up to 5%
· Employee Stock Purchase Plan (ESPP)
· Supplemental Life Insurance
· Dependent Life Insurance
· Short- and Long-Term Disability buy-up
· Blueprint for Wellness
· Emotional Well-Being Resources
· Educational Assistance
· Paid time off / Health Time
Where you'll work
West Hills, CAHybridOpen in Maps (opens in a new tab)
More jobs in West Hills, CAJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California84 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $115,000 | — | $130,000 |
| California (middle half) | $118,625 | $135,000 | $158,625 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: LABONE, LLC., d/b/a Quest Diagnostics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not LABONE, LLC., d/b/a Quest Diagnostics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 40 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- GMP and compliance11
- Lab testing and methods11
- Documentation and SOPs7
- Investigations and CAPA6
- Regulatory submissions5
- Quality systems and risk2
- Data and digital systems2
- Validation and qualification1
Company hiring pulse
LABONE, LLC., d/b/a Quest Diagnostics on Regulatory Jobs
- 9
- Open roles
- 8
- Distinct roles
- 9
- Locations
By discipline
- Quality7 78%
- Regulatory1 11%
- Compliance & Safety1 11%
By level
- Manager3 33%
- Associate & Specialist3 33%
- Director2 22%
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Specialist, Quality Assurance III (CLS Licensed) at LABONE, LLC., d/b/a Quest Diagnostics
Open until filled. $115K–$130K a year, employer provided.