Site Quality Leader
Core
Designated Site Quality Management Representative responsible for product quality, regulatory compliance, and championing a culture of quality within the manufacturing site.
Role type
Senior Site Quality Leader / Quality Assurance Manager
Builds
Finished medical device products manufactured for and by the company
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance, Quality Management Systems (QMS), Continuous Improvement, Quality Control Inspection, CAPA Methodologies, Supplier Quality Management, People Management, Risk Management, Strategic Planning, Regulatory Compliance, KPI Management, Budget Management, Business Acumen
Preferred skills
ISO13485, ISO9001, ISO14971
Responsibilities
Establish operational objectives and work plans, review and monitor operational KPIs, guide review and approval of finished products, manage talent across the quality assurance team, implement quality assurance policies and strategies, own audits and assessments processes, champion programs to improve Quality, Compliance and overall departmental productivity
Seniority
Senior, hands-on IC
