Senior Quality Systems Specialist
Core
Support the development, improvement, and implementation of Quality Systems for medical technology products.
Role type
Senior Quality Systems Specialist
Builds
Quality system procedures, policies, and regulatory compliance frameworks
Domain
Medical Technology / Regulatory Quality
Required skills
FDA medical device regulations, ISO 13485, MDSAP, EU MDR/IVDR, CAPA, Design Controls, Risk Management, Internal Audit, Supplier Quality, Quality Data Analysis
Preferred skills
Certified Quality Auditor, Six Sigma Green Belt, BD software systems
Technologies
FDA 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, EU IVDR
Responsibilities
Apply quality system standards to assigned areas, develop solutions for routine activities of moderate complexity, update procedures and policies, ensure quality conduct of projects including design and data interpretation, work across functions for assigned quality systems
Seniority
Senior, hands-on IC
