Quality Engineer

📋 Description

• Hybrid 1-3 days on-site; support audits (CLIA/CAP, ISO 13485, customer).
• CAPA, deviation, change requests and nonconformance investigations.
• Write/revise procedures; submit to Document Control; assist training.
• Perform statistical analysis and hypothesis testing (AQLs).
• Ensure quality systems comply with CLIA, FDA QSR, ISO 13485, HIPAA.
• Review manufacturing/QC batch records and follow SOPs.

🎯 Requirements

• B.S. or equivalent in science/engineering field.
• 6+ years in medical diagnostics/CLIA/life sciences; 3+ in quality.
• Audit experience – internal, third party, or regulatory.
• ASQ CQE certification preferred.
• Knowledge of CLIA/CAP, ISO 13485, FDA QSRs (21 CFR 820).
• Strong technical writing and communication skills.
• Independent, self-starter with strong organizational skills.
• Hands-on DNA isolation, PCR, cell culture, sequencing, bioinformatics (preferred).

🎁 Benefits

• Competitive benefits including medical, dental, vision.
• Fertility care benefits and free testing for employees.
• Pregnancy and baby bonding leave.
• 401k benefits and commuter benefits.
• Generous employee referral program.