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New · posted Nov 5

Quest Diagnostics · Medical Devices

QA Specialist I, Clinical Lab

  • Royal Oak, MI
  • Hybrid
  • Full-time
  • Associate & Specialist
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EmploymentFull-time
DeadlineOpen until filled

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, MI

Working 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

Middle half $56,875 to $88,625, median $77,250
Annual base pay
Annual base payLowMedianHigh
All US$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.

  1. This role

    Associate & Specialist

    Often: Quality Technician · Quality Assurance Specialist

    $77K median96 open
  2. Next step

    Senior & Principal

    Often: Quality Lead · Quality Specialist

    $117K median87 open
  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $145K median81 open
  4. Later

    Director

    Often: Director, Product Quality Leader, Biologics · Director, Quality

    $220K median72 open
  5. Later

    VP & Executive

    Often: AVP · DX Head of Regions Quality Management and Regulatory Affairs

    $325K median12 open

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.

GMP and compliance: 5 linesLab testing and methods: 11 linesDocumentation and SOPs: 8 linesInvestigations and CAPA: 2 linesValidation and qualification: 1 lineRegulatory submissions: 1 lineQuality systems and risk: 1 lineData and digital systems: 3 linesCollaboration and leadership: 7 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsData systemsTeamwork
  • 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.

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%
See all 14 Quest Diagnostics roles

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All 14 Quest Diagnostics roles

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QA Specialist I, Clinical Lab at Quest Diagnostics

Open until filled.

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