Staff Quality Engineer

About the role

Responsibilities

• Design control & DHF ownership — own Design History Files across multiple molecular assay, consumables, and instrument programs from concept through design transfer.
• Risk management — own ISO 14971 risk management files, hazard analysis, dFMEA/pFMEA/uFMEA, risk control verification, and benefit-risk rationale, feeding directly into design and process decisions.
• eQMS implementation & administration — select, implement, and administer the electronic quality management system as the backbone of document control and quality records.
• CAPA, nonconformance & deviation management — own the full loop: investigation, root cause, corrective/preventive action, effectiveness checks, and trending into management review.
• Supplier quality & purchasing controls — qualify and monitor critical suppliers, CDMO partners, and OEM chemistry sources; own incoming inspection criteria and supplier corrective actions.
• Validation — lead process validation (IQ/OQ/PQ) with defensible statistical rationale; support assay, consumables, instrument, and software validation, including computer system validation under an SDLC framework.
• Audit & certification readiness — run the internal audit program; prepare for and support notified body, supplier, and regulatory audits; drive the system toward ISO 13485 certification and IVDR technical documentation readiness.

Requirements

• Working command of FDA QMSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, ISO 14971, and cGMP.
• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Sound applied statistics for quality engineering: sampling plans, process capability, gage R&R, and method validation — able to defend the rationale, not just execute the protocol.
• Familiarity with IEC 62304 and premarket cybersecurity documentation preferred.
• Sufficient technical depth across molecular/genomics, assay chemistry, or instrumentation to review technical data and credibly challenge conclusions.

Benefits

• Medical, dental, and vision coverage
• Company-paid life insurance
• 401(k) retirement plan
• Generous paid time off
• Access to additional voluntary benefits, employee perks, and discount programs
• We are committed to supporting the well-being of our employees and providing a strong foundation for both professional and personal success.
• Dental
• Vision
• 401(k)
• PTO