Manufacturing Quality Engineer II, Sustaining (2nd Shift)
Core
Hands-on quality engineering role supporting production operations, process controls, inspection systems, and manufacturing quality improvements within precision machining operations.
Role type
Manufacturing Quality Engineer II
Builds
Production quality, process stability, and successful product transfers into commercial production for structural heart devices.
Domain
Medical device manufacturing / Precision machining
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Nonconforming material investigations, CAPA management, manufacturing quality systems, process validation, equipment validation, material review board (MRB) management, continuous improvement methodologies (Six Sigma, Lean, TOPP), risk management (pFMEA), training development, statistical process control (SPC), root cause analysis.
Preferred skills
MES systems support, Keyence inspection systems, vision systems, automated inspection technologies, new product introduction (NPI) support, FDA QSR and ISO 13485 knowledge, CNC and Swiss machining operations.
Responsibilities
Investigate manufacturing product quality and compliance issues; manage site NCRs, CAPAs, ECRs, and audit observations; provide technical support to audits; oversee product release and disposition; review and approve equipment validations; optimize manufacturing processes; collaborate on successful product transfers; develop training and documentation materials; support process validation and PMV activities; instruct and train technicians.
Seniority
Mid-level, hands-on IC