Operations Quality Assurance Lead
Core
Lead quality assurance operations, compliance, and continuous improvement initiatives for medical device products.
Role type
Senior Quality Assurance Lead (Medical Devices)
Builds
Quality compliant medical device products and processes
Domain
Medical Devices / Regulatory Quality
Required skills
Quality management systems (QMS), CAPA management, risk management, process validation, V&V, audit readiness, team leadership, NCEP/PIRE processes, complaint handling, SOP development
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead NCEP, CAPA, PIRE/PIR processes and mentoring; Lead QA Management Review, quality metrics and governance; Drive major quality, compliance and improvement initiatives; Manage QA engineers; Lead 2nd and 3rd Tier Quality meetings; Serve as Service & Field Complaints POC; Lead ZRD Special WKO activities for new and modified production processes
Seniority
Senior, hands-on IC with management responsibilities