Quality Assurance Engineer

Quality Assurance Engineer – Eurofins Clinical Diagnostics

Bridge technical operations and quality assurance in high throughput, regulated laboratories. Prevent quality failures through proactive risk and process management by monitoring lab processes, conducting audits, analyzing data to identify potential issues, and driving continuous improvement initiatives that minimize errors and ensure data integrity.

Eurofins Scientific is an international life sciences company that provides a unique range of analytical testing services to clients across multiple industries, ensuring products are safe, authentic, and accurately labeled. With 55,000 staff in 900 laboratories across 50+ countries, we offer over 200,000 analytical methods to evaluate safety, purity, and traceability of biological substances.

• Quality Management System (QMS): Maintain and improve the QMS, ensuring procedures comply with regulatory standards (CLIA, CAP, FDA, ISO 15189). Identify and investigate non‑conformances and aid in developing technical SOPs and work instructions.
• Auditing and Compliance: Provide documentation for audits, ensure validation and qualification documentation is audit ready, conduct internal lab audits, and support external regulatory inspections.
• Corrective and Preventive Actions (CAPA): Perform root‑cause analyses for system‑related failures and implement action plans.
• Process Improvement: Identify improvement opportunities, lead continuous improvement activities using Lean Six Sigma or similar tools, develop process maps and performance dashboards, and collaborate with lab operations and IT to reduce errors.
• Training: Develop and deliver QA training programs for laboratory staff.
• Collaboration: Work with lab management, technical directors, and cross‑functional teams to integrate quality requirements into daily operations and new process development, fostering a proactive quality culture.

• Education: Bachelor’s degree in chemical, biological, physical, laboratory science or related engineering field.
• Experience: 3+ years in quality engineering or process improvement, preferably in a regulated laboratory or healthcare setting.
• Regulatory Knowledge: Thorough understanding of ISO 15189, CAP, CLIA, FDA, and related standards.
• Technical
  
  Skills:
  
  Proficiency with LIMS, statistical analysis software, and Microsoft Office (especially Excel). Experience with Lean Six Sigma, SPC, VSM, RCA, and CAPA.
• Problem‑Solving: Strong analytical and root‑cause analysis abilities.
• Communication: Excellent written and verbal skills, capable of presenting data to diverse stakeholders.
• Attention to Detail: Meticulous detail orientation and high accuracy in documentation.
• Work Environment: Ability to work independently and collaboratively in a fast‑paced, deadline‑driven laboratory environment, potentially involving biohazards or PPE.

$90,000 – $110,000 per year

Monday – Friday, 8:00 am – 4:30 pm

• Comprehensive medical, dental, and vision coverage
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Mid‑Senior level

Full‑time

Quality Assurance

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.