Quality Engineer

Job Responsibilities:

• Lead and support investigations into deviations, NCRs, and complaints, ensuring root cause is identified and effective CAPAs are implemented.

• Review validation documentation (IQ/OQ/PQ), change controls, and technical reports for quality impact.

• Conduct risk assessments using FMEA, HACCP, or equivalent tools and participate in design reviews for new equipment or processes.

• Partner with QA and Manufacturing to maintain audit readiness and ensure compliance with FDA, EU, and internal QMS standards.

• Analyze quality trends, generate dashboards, and drive initiatives to reduce quality events and improve product reliability.

Qualifications:

• B.S. in Engineering, Life Sciences, or related field.

• 3–6 years of experience in Quality Engineering in a regulated manufacturing setting.

• Knowledge of 21 CFR Part 210/211 (pharma) or ISO 13485 (med device).

• Proven track record managing investigations, CAPAs, and quality system documentation.