Quality Engineer Manager - Pilot Operations
Core
Lead the Pilot Quality Operations function for new product development and clinical builds, ensuring integrity and safety from feasibility studies through product transfer to commercial manufacturing.
Role type
Manager, Quality Engineering (Medical Devices)
Builds
Pilot manufacturing lines for feasibility/design verification, first-in-human/clinical builds, and limited volume commercial manufacturing.
Domain
Medical device manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering, Quality Management, Regulatory Compliance, Process FMEA, IQ/OQ/PQ validation, Design of Experiments, Statistical Process Control, Lean and 6-sigma tools, CAPA management, Product transfer management
Preferred skills
Black Belt certification, Project Management, Technical leadership, Engineering experience with medical devices, Statistical analysis, Financial acumen
Technologies
Lean, 6-sigma, FMEA, IQ/OQ/PQ, CAPA
Responsibilities
Direct supervision and development of a group of Quality Engineers; Plan and direct operational and project activities; Lead test method validation activities and Process FMEAs; Collaborate with R&D/NPD to identify DFM opportunities; Drive implementation of Critical Control Points; Responsible for release/rejection/disposition of pilot products; Support product transfer from Pilot to commercial manufacturing sites.
Seniority
Manager, team leadership (3+ direct reports)