Quality Engineer
Core
Primary quality representative supporting manufacturing operations and product lifecycle management for medical devices.
Role type
Quality Engineer (Manufacturing)
Builds
Medical devices for Afib treatment and pain relief (via careerplan.io/jobs/4372675009-quality-engineer-at-atricure-inc)
Domain
Medical Devices / Manufacturing
Required skills
Risk management, Process validation, Design verification/validation, FDA/ISO 13485 compliance, Metrology, Data analysis, GD&T interpretation, Lean Manufacturing tools, Problem solving
Preferred skills
Medical device industry experience, Sterilization processes (EO/Gamma), Regulatory experience, Design background
Responsibilities
Manage NCR, Investigation, FMEAs, Rework, Deviations, and CAPA activities; Chair Material Review Board (MRB); Lead risk assessments and control measures; Analyze quality metrics and drive improvement initiatives; Support new product development and transfer; Execute process validation and equipment qualification protocols; Assist with FDA and ISO audits.
Seniority
Mid-level, hands-on IC