Sr. Manager, Quality
Core
Guide strategic quality initiatives, oversee quality management systems, and ensure regulatory compliance to enable customers to make the world healthier, cleaner, and safer.
Role type
Senior Manager, Quality
Builds
Quality management systems and regulatory compliance frameworks
Domain
Life Sciences / Medical Devices / Pharmaceuticals
Required skills
Quality management systems (QMS), Global regulatory standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR), GMP, Quality investigations, CAPA, Change control, Risk analysis (FMEA), Root cause analysis, Continuous improvement (PPI), Cross-functional leadership, Data analysis
Preferred skills
ASQ certification, Lean Six Sigma, Science/Engineering/Chemistry degree
Technologies
Quality management software systems
Responsibilities
Manage quality assurance and quality control teams, Lead quality investigations and implement CAPA, Host regulatory inspections and customer audits, Develop quality professionals, Implement data-driven solutions to enhance quality systems
Seniority
Senior, hands-on IC