Manager Quality Compliance
Core
Oversee site Document Control, ensure regulatory compliance (ISO 13485, FDA), lead internal audits, and manage quality governance forums for a medical device company.
Role type
Manager, Quality Compliance
Builds
Safe, effective continuous glucose monitoring devices and other medical biosensing products
Domain
Medical Devices / Continuous Glucose Monitoring (CGM)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance management, Document Control oversight, Internal Audit program leadership, CAPA management, Root cause analysis, Risk-based decision making, Technical writing, Cross-functional leadership
Preferred skills
ASQ certification (CQE, CRE, CQM), Lean Six Sigma, Experimental design
Technologies
ISO 13485, FDA 21 CFR 820, QMS, FMEA, DOE
Responsibilities
Oversee Document Control team for QMS document lifecycle; Ensure compliance with ISO 13485 and FDA standards; Facilitate internal/external audits; Lead remediation of quality gaps; Develop and report compliance metrics; Manage site Internal Audit program; Lead Quality, CAPA, and MRB governance forums; Manage a team of Quality Assurance personnel
Seniority
Manager, 8-12 years experience + 2-5 years management