Quality Manager, NPI
Core
Lead quality strategies and team management to ensure compliant onboarding of new medical device products from development through commercial launch.
Role type
Senior Quality Manager, New Product Introduction (NPI)
Builds
New product launches for biopharma and medical device clients
Domain
Medical Devices / Biopharma / Contract Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality strategy development, NPI program management, cross-functional team leadership, client relationship management, risk assessment (FMEA), regulatory compliance (FDA/ISO/ICH), technical writing, root cause analysis (RCA), CAPA leadership, Lean/Six Sigma, equipment qualification, GMP adherence
Preferred skills
Lean Six Sigma Certification, ASQ CQE, Test Method validation, Sterilization processes
Technologies
ERP systems, electronic Quality Management Systems (eQMS), Microsoft Office
Responsibilities
Lead development and execution of quality strategies for new product onboarding, serve as primary quality contact for client interactions and technical transfers, manage quality deliverables and timelines for project milestones, lead quality review of batch records and documentation, participate in risk assessments and drive corrective actions, ensure smooth transition from NPI to routine manufacturing, manage day-to-day activities of quality team members
Seniority
Manager, supervisory role
