Senior Manager, Quality Engineering - Manufacturing Operations
Core
People leadership and manufacturing role providing quality and compliance oversight for structural heart device production.
Role type
Senior Manager, Quality Engineering (Manufacturing)
Builds
Compliant manufacturing operations for THV, TMTT, advanced catheters, and metals (via careerplan.io/jobs/Req-51162-senior-manager-quality-engineering-manufacturing-operations-at-edwards)
Domain
Medical device manufacturing
Required skills
People leadership, Quality Management Systems (ISO 13485, 21 CFR Part 820), CAPA execution, Nonconformance Report (NCR) management, Root cause analysis, Validation oversight (IQ/OQ/PQ), Supplier quality management, Audit support, Risk management
Preferred skills
Engineering or Scientific degree, Medical device manufacturing experience, Microbiology principles, Cleanroom qualification, Statistical methods, Process capability, Change management
Technologies
ISO 13485, 21 CFR Part 820
Responsibilities
Lead and develop a team of Quality Engineers; oversee NCR and CAPA execution; monitor operational quality metrics; support internal and external audits; partner with Operations and Engineering to resolve quality issues; establish shift-to-shift communication processes.
Seniority
Senior, hands-on IC with people leadership