Quality Assurance Leader
Core
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements and that projects and products meet specified standards.
Role type
Senior individual contributor Quality Assurance Leader
Builds
Total quality management system for the business, quality metrics, and regulatory compliance frameworks
Domain
Medical technology and digital solutions
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Systems Engineering, Validation & Verification, Change deployment, Risk management, CAPA, ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, IMDR, packaging specifications review, test reports review, validation protocols review
Preferred skills
ISO/MDSAP/Notified Body audits, FDA Inspections, ASQ certification, Six Sigma, LEAN manufacturing
Technologies
ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, IMDR
Responsibilities
Drive compliance activities around a specific product, site or region; Execute and drive quality objectives, metrics, reporting and operating mechanisms; Partner with Engineering and cross functional teams to ensure adequate Design controls; Support program teams to complete Quality and QMS deliverables; Ensure internal and external Audit readiness; Evaluate identified risks using risk management tools and deploy mitigation actions; Align packaging processes with QMS & regulatory requirements across regions
Seniority
Senior, hands-on IC