New · posted Oct 15
LABONE, LLC., d/b/a Quest Diagnostics · Medical Devices
Specialist, Quality Assurance
- Saint Joseph, MI
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Contribute to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs.
This is an Onsite position at 1234 Napier Ave supporting our Corewell Health South Hospital Sites.
Travel: Up to to 25% or less.
- Manage Proficiency Testing Program (CAP and NYS) for the laboratory - maintain data base and produce monthly summaries.
- Manage the Document Control System. Support compliance with document control policies for all procedures and related documents.
- Assist in the prompt and complete reporting of Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP.
- Conduct internal audits to ensure laboratory is inspection ready at all times.
- Assist with external audits.
- Review protocols and make recommendations to enhance QA Program.
- Coordinate compliance with applicable regulations through documentation, audits, and corrective action.
- Perform reviews of departmental quality records. Collaborate with management in the testing department to investigate and resolve nonconformances.
- Audit training and competency program.
- Promote continuous quality improvement by collaborating with management to implement standardization and process improvement.
- Perform special projects as assigned.
- Perform other duties as assigned to meet the business needs or customer requirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.
What you need
Required Work Experience
Minimum two (2) to three (3) years technical laboratory experience.
Education
- Bachelor’s Degree BA/BS Degree in a Life Sciences preferred. Equivalent combination of education and experience. (considered)
Physical and Mental Requirements
- The normal performance of duties may require lifting and carrying objects: Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to 25 pounds are lifted and carried occasionally; objects 36 to 50 pounds are seldom lifted or carried and objects over 50 pounds are not to be lifted or carried without assistance.
- Ability to sit or stand for long periods of time.
Knowledge
- Basic theoretical and operational job knowledge in quality assurance and laboratory operations.
- Knowledge of organizational/departmental policies and procedures.
- Demonstrate leadership skills through accountability, integrity, and collaboration in daily tasks.
- Excellent interpersonal and communication skills (oral and written) necessary to effectively interact with all levels of staff.
- Project a positive, professional demeanor.
- Communicate with employees in a manner that creates an informed, positive environment.
- Facilitate efforts to work with others in a way that promotes teamwork and change.
- Must be detail-oriented, have the ability to work independently, establish work priorities and to handle several tasks simultaneously.
- Strong organizational and prioritization skills.
- Proven problem-solving skills with the ability to develop appropriate resolutions.
- Proficiency in Microsoft Office (Word, Excel and Outlook) and Laboratory Information Systems.
Licenses and Certifications
- ASCP Certification (Preferred)
Preferred Work Experiencenice to have
Previous experience with Quality Assurance and laboratory regulations preferred.
Where you'll work
Saint Joseph, MIOn-siteOpen in Maps (opens in a new tab)
More jobs in Saint Joseph, MIJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $78,500 | $94,000 |
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 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Lab testing and methods8
- Collaboration and leadership7
- Documentation and SOPs5
- Investigations and CAPA1
- Quality systems and risk1
- Data and digital systems1
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 at LABONE, LLC., d/b/a Quest Diagnostics
Open until filled.