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.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).