Senior Manager, Quality Engineering - Manufacturing Operations (2nd Shift)
Core
Senior leadership role overseeing quality and compliance for second-shift manufacturing operations, managing a team of Quality Engineers and ensuring adherence to regulatory standards across major production areas.
Role type
Senior Manager, Quality Engineering (Manufacturing Operations)
Builds
Compliant manufacturing operations for THV, TMTT, advanced catheters, and metals products
Domain
Medical device manufacturing / Quality Engineering
Required skills
People leadership, Quality Management Systems (ISO 13485, 21 CFR Part 820), CAPA execution, Nonconformance Report (NCR) management, Root cause analysis, Shift-to-shift communication, Audit support, Supplier quality management
Preferred skills
Engineering or Scientific degree, Medical device manufacturing experience, Microbiology principles, Cleanroom qualification, Statistical methods, Process capability, Risk management, Change management
Technologies
ISO 13485, 21 CFR Part 820, IQ/OQ/PQ validation tools
Responsibilities
Lead and develop a team of Quality Engineers for second-shift operations; Oversee NCR and CAPA execution including root cause analysis and effectiveness verification; Monitor quality metrics and trends to identify emerging risks; 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
