Manager, Design Quality - Lifecycle Management
Core
Ensuring quality system compliance and managing the transfer of medical devices and combination products from development to manufacturing and lifecycle changes.
Role type
Manager, Design Quality - Lifecycle Management
Builds
Medical devices and combination products (Consumer Eyecare, Ocular Implants, Pre-filled Syringes, Autoinjectors, Aesthetic Devices)
Domain
Medical Devices / Pharmaceutical / Regulatory Compliance
Deliverable
client delivery
Required skills
Quality Assurance Operations Management, Design Control, Change Control, Process Validation (IQ/OQ/PQ/PPQ), Risk Management, Regulatory Inspections, Cross-functional Leadership, Project Management
Preferred skills
Eyecare products, PFS, Autoinjector, On Body Injector, Biological/Pharmaceutical technologies
Technologies
ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC, EU Regulation 2017/745
Responsibilities
Lead design transfer activities and process validation; Manage on-market design changes and change plans; Support regulatory inspections and audits; Identify gaps in Design History File and Risk Management; Lead cross-functional teams for solution development; Conduct investigations and review boards for CAPAs and NCRs.
Seniority
Manager, hands-on IC with strategic oversight