Job Description

About the Role

We are seeking a highly skilled Sr. Quality Specialist to join our QA Reagents team. This role requires strong self-direction, excellent attention to detail, and the ability to work effectively in a fast-paced manufacturing environment. You will collaborate across departments, support quality system improvements, and ensure that products and processes meet regulatory, internal, and customer requirements.

The Sr. Quality Specialist plays a key role in reviewing high-level documentation, resolving non-conformances, supporting investigations, participating in process improvements, and ensuring the timely release of materials and finished goods.

What You’ll Do

Global Responsibilities

• Conduct final reviews of batch records to ensure compliance with internal and regulatory quality standards.
• Release product batches within established timelines.
• Lead quality investigations, including root cause analysis and corrective/preventive actions (CAPA).
• Review and approve risk analyses, manufacturing documentation, and change-related quality records.
• Support or perform troubleshooting for manufacturing discrepancies and defects.
• Assist with audits, customer complaints, and quality investigations.
• Train team members on documentation review processes and quality requirements.
• Maintain proper archiving and retrieval of batch records, ensuring audit readiness.
• Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.

Local Responsibilities

1. Inspect product (including labeling) for compliance with procedures and specifications; determine product acceptance.
2. Identify and escalate non‑conformances; partner with production to resolve issues where appropriate.
3. Ensure accurate documentation practices during quality record review; resolve errors with production teams.
4. Physically release work‑in‑process for finished-goods production and archive quality records.
5. Prioritize product release to meet departmental goals; report floor failures observed during routine sweeps.
6. Review and approve Device History Records (DHRs). Receive and hold finished goods until authorized release.
7. Release finished goods to stock; coordinate molded part validation inventory.
8. Verify equipment meets requirements for release to Manufacturing Engineering for validation.
9. Confirm equipment meets specifications for release to Reagent Manufacturing for use.
10. Physically and electronically control all suspected non‑conforming material; review Nonconforming Product Reports (NCRs).
11. Review and approve rework documentation; confirm it meets quality requirements.
12. Disposition NCR‑related materials.
13. Manage Temporary Change Orders (TCOs) to ensure proper documentation across applicable records.
14. Track TCO activation/expiration to determine when to remove, revise, or escalate to full change orders.
15. Confirm all required validation documentation is completed prior to product release; control validation-related product until criteria are met.
16. Perform all work in compliance with company quality standards.
17. Perform other duties as assigned.

What You Bring

Required Qualifications

Training and Education:
1. High school diploma or equivalent is required
2. Associate degree (or higher) in a life science or engineering discipline is preferred.
3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
4. Completion of the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree).

Physical & Working Conditions

• Ability to remain in a stationary position (sitting or standing) for extended periods.
• Ability to correctly wear PPE throughout the workday.
• Ability to lift or move up to 50 lbs.
• No domestic or international travel required.

Why Join Us?

As a Sr. Quality Specialist, you will directly contribute to the quality and reliability of products that make a meaningful difference. You will help lead documentation integrity, product release, investigations, and continuous improvement efforts—playing a crucial role in maintaining our high-quality standards.

The pay for this role is between $29.50 to $38.00. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. · Adoption Assistance · Wellness Programs · Employee Assistance Program · Commuter Benefits · Various voluntary benefit offerings · Discount programs · Parental leaves