Sr. Manager of Quality Assurance
Core
Strategic leadership role ensuring compliance, effectiveness, and continuous improvement of the Quality Management System (QMS) and Class 3 PMA medical device products.
Role type
Senior Manager of Quality Assurance (Strategic Leadership)
Builds
Medical device products for cardiopulmonary and respiratory conditions
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS management, regulatory compliance (FDA, ISO 13485, MDR), team leadership, CAPA strategy, risk management, change control, PLM, data analysis, project management
Preferred skills
Master's in Engineering or MBA, 4+ years QA engineering experience, ASQ CQE/CRE/CQM certification, Lean Six Sigma
Technologies
ISO 13485, ISO 14971, 21 CFR 820, MDR, Lean Six Sigma, DMAIC, Gage R&R, Design of Experiments
Responsibilities
Manage inspection and product release programs, liaise with external auditors, monitor QA processes and schedules, lead Quality Engineering and Inspection Departments, drive cross-functional collaboration for complex quality issues, create inspection instructions and perform trend analysis, lead company-wide strategy for CAPA, risk management, change control, and PLM
Seniority
Senior, hands-on IC with strategic oversight