Sr. Quality Engineer
Core
Ensure manufacturing processes comply with quality standards, monitor notifications and defect trends, and implement corrective actions for medical device production.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Robotic-assisted surgical systems and minimally invasive care technologies
Domain
Medical devices / Robotic surgery
Required skills
ISO 13485, 21CFR820, CAPA, Root Cause Analysis, Process Validation, Statistical Process Control (SPC), Design of Experiments (DOE), Measurement System Analysis (MSA), PFMEA, Lean Manufacturing, Six Sigma, SAP, Minitab
Preferred skills
Minitab, Lean Manufacturing
Technologies
SAP, Agile, Minitab
Responsibilities
Monitor quality notifications (VRs, NCRs, EEs) and perform root cause analysis; Participate in process and product validations; Conduct improvement projects for defect reduction; Mentor new quality engineers; Participate in customer complaint investigations; Prepare trend reports and audit preparations.
Seniority
Senior, hands-on IC