Engineer III, QA
Core
Ensures quality engineering support for bioprocessing equipment automation products, manufacturing, and quality systems to meet regulatory and business requirements.
Role type
Senior IC Quality Engineer (Bioprocessing)
Builds
Bioprocessing equipment and automation solutions for biopharmaceutical manufacturers
Domain
Life Sciences / Bioprocessing / Regulated Manufacturing
Required skills
GMP compliance, CAPA management, root cause analysis, risk assessment (FMEA), validation support, cross-functional collaboration, eQMS proficiency, regulatory inspection support (via careerplan.io/jobs/R-01356446-engineer-iii-qa-at-thermofisher)
Preferred skills
ASQ CQE/CQA certification, ISO 13485 knowledge, bioprocessing equipment expertise, statistical analysis, SAP/ERP familiarity, Power BI
Technologies
TrackWise, MasterControl, Microsoft Office, SAP, Power BI
Responsibilities
Lead CAPA, deviation, and change control activities; conduct root cause analysis for quality issues; support validation and qualification activities; participate in internal and customer audits; analyze quality data trends for continuous improvement.
Seniority
Senior, hands-on IC