Quality Manager - Fuze Services
Core
Implement best practice initiatives to improve process capability and ensure regulatory compliance for medical device manufacturing.
Role type
Senior IC Quality Manager (Medical Devices/IVD)
Builds
Quality Management Systems (QMS) compliant with ISO 13485, 21 CFR 820, EU MDR, and EU IVDR
Domain
Medical Device Manufacturing / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS governance, regulatory compliance (ISO 13485, 21 CFR 820, EU MDR, EU IVDR), eQMS management, change control, team leadership, risk management (ISO 14971), internal/external audits, CAPA, root-cause analysis, Lean/Six Sigma
Preferred skills
Medical device software experience, electromechanical device knowledge, sterilization processes, regulatory submissions, cleanroom environment experience, cross-functional collaboration
Technologies
eQMS platforms, Risk Management software
Responsibilities
Serve as Management Representative and PRRC; oversee eQMS implementation and change control; manage Quality personnel and training; maintain Risk Management program; lead internal audits and participate in third-party audits; drive CAPA and continuous improvement; execute design and improvement projects; provide site support and travel.
Seniority
Senior, hands-on IC
