Associate Quality Engineer

📋 Description

• Support internal and external audits (CLIA/CAP, ISO 13485, customer)
• Support CAPA, deviations and nonconformance investigations
• Write/revise procedures and forms
• Perform statistical analysis and hypothesis testing (AQL)
• Ensure compliance with CLIA, FDA QSR, ISO 13485, and HIPAA
• Review manufacturing and QC batch records

🎯 Requirements

• BS or equivalent in science, engineering or related field
• 4+ years in medical diagnostics, CLIA, or life sciences; 2+ years in Quality preferred
• Audit experience – internal, third party, or regulatory audits
• ASQ CQE certification preferred
• Knowledge of CLIA/CAP, ISO 13485, FDA QSRs (21 CFR 820)
• Computer skills: MS Word, Excel, PowerPoint
• Hands-on DNA isolation, PCR, cell culture, sequencing, bioinformatics
• Strong judgment, attention to detail, and collaboration on multiple projects

🎁 Benefits

• Competitive medical, dental, vision, life and disability coverage
• Free testing for employees and immediate family; fertility care benefits
• 401(k) plan and commuter benefits
• Generous employee referral program