Sr. Manager, Quality Engineering ADD
Core
Lead Quality Engineering teams to ensure design transfer, control, and assurance for advanced drug delivery products, managing risk, deviations, and regulatory compliance.
Role type
Senior Manager, Quality Engineering (Medical Device/Pharma)
Builds
Quality systems and compliant product launches for biopharma clients
Domain
Medical Device / Advanced Drug Delivery / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, statistical analysis, root cause analysis, design control, change management, supplier quality, measurement system analysis, regulatory strategy, team leadership, budget management
Preferred skills
Lean Six Sigma, technical writing, test method validation, MSA expertise, process improvement
Technologies
ERP, eQMS, MS Office, statistical software
Responsibilities
Provide strategy and leadership over QE teams at multiple sites; oversee New Product Introduction and tech transfer; serve as SME for Design Control and Risk Management; approve investigations and supplier nonconformances; manage resource allocation and workload planning; lead statistical assessments and root cause investigations; ensure compliance with ISO 13485 and FDA 21 CFR 820; manage departmental budget and spending; support recruitment and development of Quality Engineers.
Seniority
Senior Manager, supervisory role with 10+ direct reports
