Engineer II, QA
Core
Ensure compliance with quality standards and regulatory requirements across manufacturing operations, lead investigations, and implement corrective actions.
Role type
Quality Engineer II
Builds
Quality oversight for critical medical devices, pharmaceuticals, or biotechnology products
Domain
Life Sciences / Medical Devices / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems knowledge (cGMP, ISO 13485, 21 CFR Part 820), Risk management, Root cause analysis, CAPA, Change control, Internal audits, Statistical analysis, Technical writing, Quality management software proficiency
Preferred skills
Life Sciences, Engineering, Chemistry background
Technologies
TrackWise, SAP QM
Responsibilities
Retrieve and process customer complaints, Lead resolution of quality issues on manufacturing floor, Establish QC inspection criteria and train technicians, Participate in product qualification and review test protocols, Issue RMAs for failure analysis, Review change orders and deviations, Provide quality data trends to management, Participate in internal audits, Act as Operation QA Representative for NPI and Transfer projects, Act as customer representative for audits and inquiries, Lead quality initiatives for continual improvement
Seniority
Mid-level IC