

New · posted Nov 5
Quest Diagnostics · Medical Devices
QA Specialist I, Clinical Lab
- Royal Oak, MI
- Hybrid
- Full-time
- Associate & Specialist
The role
The Quality Assurance Specialist I is responsible for supporting, coordinating, and executing quality assurance activities at the local department or facility level. Under the guidance of QA leadership, this role assists in ensuring that all pre-analytical, analytical, and post-analytical processes are consistent with Quest Diagnostics' standard operating policies and procedures. This role focuses on data collection, maintaining databases, auditing departmental activities licensure support, investigations, regulatory compliance activities, tracking employee training and competency records and ensuring inspection readiness.
The QA Specialist I position is hybrid and can work from the Quest/Corewell hospital lab based in Grand Rapids or Royal Oak, MI. The team will consider additional Quest/Corewell lab sites depending on a candidate's location in MI.
Strategic Quality Management
- Collects, tracks, and supports monthly departmental Quality Indicators and daily management system data.
- Assists with monitoring data collection for performance reportables.
- Formats and presents data summaries to key stakeholders.
Compliance & Audit Management
- Conducts routine internal, audits including in laboratory inspection/GEMBA and desk audits; documents observations and recommendations.
- Prepares for external inspections (CAP, CLIA, etc.) and may support safety standard oversight.
- Gathers data for report approvals and processes QA payments/invoices for key materials such as proficiency testing surveys.
Continuous Improvement
- Performs routine QA data pulls and tracks quality trends.
- Flags local issues (revised reports, complaints) and supports quality investigations / quality event investigations and inquiries.
- Executes non-complex corrective actions.
- Performs data transmission electronic interface tests as required.
Quality Systems Oversight
- Assists with document control program including enterprise software applications.
- Supports local SOP routing, forms development and distribution.
- Tracks PT enrollment, compiles results, executes PT processes (e.g., ordering, cancelling), and supports comparison studies.
- Supports basic tasks and reviews competency completion and identifies gaps.
- Periodic assessment activities such as monitoring equipment issues, preventative maintenance, temperature logs, water cultures, validation reviews, and routine laboratory activities.
- Supports government agency reporting as needed.
What you need
Required Work Experience
- 1+ year in a Clinical Laboratory setting or healthcare/life sciences.
Education
- BS/BA in Medical Technology, Chemistry, Biology, or related Science field. (Required)
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
- Basic working knowledge of laboratory regulations and standards (i.e., CMS, CAP, CLIA) and the accreditation processes.
- Working understanding of Laboratory Information Systems (LIS).
- Proficiency in Microsoft Office applications (Word, Excel, Outlook, Teams).
- Detail-oriented.
- Strong organizational and prioritization skills.
- Effective verbal, written, and interpersonal communication skills.
- Ability to track and closely monitor records management.
- Ability to interact collaboratively with lab management and influence change and outcomes.
- Intermediate analytical and problem-solving skills.
Technical Training or Professional Licensing
- State clinical laboratory licensure and/or certification where applicable, required.
- ASCP (MLT/MT) or equivalent, preferred.
Preferred Work Experiencenice to have
- 1+ years of exposure to basic quality systems, point of care coordination, or specimen processing QA.
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.
Where you'll work
Royal Oak, MIHybridOpen in Maps (opens in a new tab)
More jobs in Royal Oak, MIWorking conditions
- Professional corporate office and clinical laboratory environment. Active biohazard precautions as required when accessing clinical laboratory areas.
Occasional travel between Quest/Corewell sites required.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US72 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $56,875 | $77,250 | $88,625 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 348 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Quest Diagnostics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods11
- Documentation and SOPs8
- Collaboration and leadership7
- GMP and compliance5
- Data and digital systems3
- Investigations and CAPA2
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in medical devices, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 15189(official source, opens in a new tab)Quality and competence of medical laboratories
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
Company hiring pulse
Quest Diagnostics on Regulatory Jobs
- 14
- Open roles
- 13
- Distinct roles
- 13
- Locations
By discipline
- Quality12 86%
- Regulatory2 14%
By level
- Associate & Specialist5 36%
- Manager4 29%
- Director3 21%
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QA Specialist I, Clinical Lab at Quest Diagnostics
Open until filled.


