Sr Engineer (Quality)
Core
Analyze, implement, and execute processes to ensure product quality for medical devices and drugs.
Role type
Senior Quality Engineer
Builds
Quality systems, corrective actions, and compliance reports for medical device and drug manufacturing.
Domain
Medical Device / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, regulatory compliance (21 CFR 820, 210, 211), risk assessment, change control, statistical analysis, manufacturing process understanding
Preferred skills
CQE certification, Lean manufacturing, Six Sigma, Project Management, EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control
Technologies
Excel (PivotTables, trending, charting), statistical software
Responsibilities
Utilize project management skills to ensure timely completion of quality programs; Support internal and external audits; Monitor quality metrics and identify continuous improvement opportunities; Gather and analyze data for root cause analysis and CAPA implementation; Support complaint sample evaluations and investigations; Serve as quality representative for New Product Development; Actively contribute to Change Review Board; Ensure compliance to regulatory requirements and quality systems
Seniority
Senior, hands-on IC