Manager, Quality, PPC - Surgery
Core
Ensures quality and regulatory compliance for a large medical device facility while driving process efficiency and leading supply chain quality activities.
Role type
Manager, Quality (Medical Device Manufacturing)
Builds
Production and Process Control, Lean, and Supplier Quality operations
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality System audits, product holds, site operations)
Required skills
Medical Device QMS, FDA CFR 21 Part 820, ISO 13485, CAPA, Root-cause analysis, Audit leadership, Budget management, People leadership, Regulatory agency liaison
Preferred skills
Six Sigma, Design controls, Design verification and validation, Change management, Cross-functional influence
Technologies
Word processing, Spreadsheet, Presentation software
Responsibilities
Ensure quality and regulatory compliance while driving process effectiveness; Represent company to external agencies and champion quality culture; Maintain and improve Site Quality Planning; Lead direct reports and influence policy; Oversee quality communications and training; Ensure audit readiness and host Quality System audits; Support CAPA activities and report on system effectiveness; Drive definition of quality objectives and metrics.
Seniority
Manager, hands-on leadership with direct reports