Engineer II, QA
Core
Quality Engineer supporting bioprocessing equipment automation products, manufacturing, and quality systems to ensure compliance with cGMP, ISO, and FDA standards.
Role type
Quality Engineer II (IC)
Builds
Production ML models | product features | dashboards & analysis | client delivery | infrastructure
Domain
Life Sciences / Bioprocessing / Quality Engineering
Required skills
cGMP/ISO/FDA regulatory knowledge, CAPA/deviation/change control management, validation (IQ/OQ/PQ) support, root cause analysis (FMEA/8D), technical writing, cross-functional collaboration
Preferred skills
ISO 13485/FDA Lead Auditor certification, ASQ CQE/CQA, bioprocessing equipment experience, eQMS proficiency, statistical analysis
Technologies
TrackWise, SAP QM, Microsoft Office, Power BI, ERP systems
Responsibilities
Support CAPA, nonconformance, deviation, and change control activities; Review and approve validation protocols and qualification reports; Lead or support quality investigations and root cause analysis; Partner with cross-functional teams to resolve quality issues; Assist with internal, customer, and regulatory audits
Seniority
Mid-level IC
