Quality Assurance Engineer

Eurofins USA Clinical Diagnostics • Centennial, CO

58d • $90,000 - $110,000

About The Position

The Quality Assurance (QA) Engineer will be responsible for bridging technical operations and quality assurance. Valuable in high throughput, regulated labs, and are key to preventing quality failures through proactive risk and process management. This role involves monitoring lab processes, conducting audits, analyzing data to identify potential issues, and driving continuous improvement initiatives to minimize errors and ensure data integrity.

Requirements

• Education: Bachelor's degree in a chemical, biological, physical, laboratory science or related science or engineering field.
• Experience: 3+ years of experience in a Quality Engineering or Process Improvement preferable in a regulated laboratory or healthcare setting.
• Regulatory Knowledge: Thorough understanding of industry-specific quality standards and regulations (e.g., ISO 15189, CAP, CLIA, FDA, etc.).
• Technical Skills: Proficiency with Laboratory Information Management Systems (LIMS), statistical analysis software, and Microsoft Office (especially Excel for data analysis). Experience with Lean Six Sigma, Statistical Process Control, Value Stream Mapping, Root Cause Analysis, CAPA, etc. is key toward process improvement role.
• Problem-Solving: Strong analytical and problem-solving abilities with experience in root cause analysis.
• Communication: Excellent written and verbal communication skills, with the ability to present data and reports to diverse stakeholders.
• Attention to Detail: Meticulous attention to detail and a high level of accuracy in all documentation and processes.
• Work Environment: Ability to work independently and collaboratively in a fast-paced, deadline-driven laboratory environment, which may involve working with potential biohazards or wearing personal protective equipment (PPE).

Responsibilities

• Quality Management System (QMS): Participate in the maintenance and improvement of the QMS. Help ensure that procedures are compliance with regulatory standards (e.g. CLIA, CAP, FDA, ISO 15189). Identify and investigate non-conformances. Assist in developing technical SOPs and work instructions.
• Auditing and Compliance: Provide technical documentation for audits and inspections. Ensure all validation and qualification documentation is complete and audit ready. Plan and conduct internal audits of laboratory operations, processes, and systems to assess compliance with established quality standards and regulations. Support external audits and inspections from regulatory agencies.
• Corrective and Preventive Actions (CAPA): Conduct technical root cause analyses for system-related failures or deviations. Help develop and implement Action Plans.
• Process Improvement: Identify areas for process improvement and lead continuous improvement activities. Utilize Lean Six Sigma or other quality tools to identify inefficiencies. Develop and maintain process maps, value stream maps and other visual tools to identify bottlenecks and opportunities. Collaborate with lab operations and IT to improve workflows and reduce errors. Develop and use statistical analysis and quality control charts to monitor trends and recommend solutions for enhanced quality and efficiency. Assist in the development and refinement of quality metrics and dashboards.
• Training: Assist in the development and delivery of quality assurance training programs for laboratory staff to ensure adherence to quality protocols and procedures.
• Collaboration: Work closely with lab management, technical directors, and other cross-functional teams to integrate process improvements and quality requirements into daily operations and new process development. Contribute to the evolution of a proactive quality culture, aligned with our service vision and mission

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees