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Eurofins Clinical Diagnostics · 5 hours ago

Quality Assurance Engineer

Centennial, CO

Full-time

Onsite

Mid Level

$90K/yr - $110K/yr

3+ years exp

Eurofins Clinical Diagnostics is an international life sciences company providing analytical testing services to ensure safety and authenticity across various industries. The Quality Assurance Engineer will bridge technical operations and quality assurance by monitoring lab processes, conducting audits, and driving continuous improvement initiatives to minimize errors and ensure data integrity.

Biotechnology

Responsibilities

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

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

Conduct technical root cause analyses for system-related failures or deviations. Help develop and implement Action Plans

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

Assist in the development and delivery of quality assurance training programs for laboratory staff to ensure adherence to quality protocols and procedures

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

Qualification

Quality Management SystemRegulatory KnowledgeLean Six SigmaLaboratory Information Management SystemsStatistical AnalysisProblem-SolvingCommunicationAttention to Detail

Required

Bachelor's degree in a chemical, biological, physical, laboratory science or related science or engineering field

3+ years of experience in a Quality Engineering or Process Improvement preferable in a regulated laboratory or healthcare setting

Thorough understanding of industry-specific quality standards and regulations (e.g., ISO 15189, CAP, CLIA, FDA, etc.)

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

Strong analytical and problem-solving abilities with experience in root cause analysis

Excellent written and verbal communication skills, with the ability to present data and reports to diverse stakeholders

Meticulous attention to detail and a high level of accuracy in all documentation and processes

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)