Sr Quality Engineer
Core
Provide quality leadership and oversight for manufacturing daily activities, ensuring products and processes meet regulatory and business requirements.
Role type
Senior IC Quality Engineer (Manufacturing)
Builds
Medical devices and manufacturing processes for patients
Domain
Healthcare technology / Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP, FDA regulations, ISO 13485, Quality System Regulations, CAPA, NCMR, root cause analysis, statistical analysis (Minitab, SPC), Lean Six Sigma, manufacturing process controls, digital quality systems
Preferred skills
Coaching and developing junior engineers, leading site-wide quality culture initiatives
Technologies
Minitab, SPC, digital quality systems
Responsibilities
Develop and maintain quality standards and protocols for material processing; collaborate with engineering and manufacturing to ensure quality standards; devise and implement inspection and testing methods; conduct quality assurance tests and statistical analysis; ensure corrective measures meet reliability standards and documentation compliance; lead complex investigations and improvement projects.
Seniority
Senior, hands-on IC
