Quality Assurance Lead Engineer
Core
Provides engineering processes and QMS management support for the Patient Care Solutions business, driving compliance and quality metrics.
Role type
Senior IC Quality Assurance Lead Engineer
Builds
Quality Management System (QMS) for medical device design, transfer, and deployment
Domain
Medical Devices / Healthcare
Required skills
Medical Device QMS requirements, FDA CFR 21 820, ISO 13485, Regulatory compliance, Process effectiveness, Quality metrics, Design controls, CAPA, Risk management, Six Sigma, Root-cause analysis
Preferred skills
Product development lifecycles, Design change control, Process verification and validation, Manufacturing process control, Continuous improvement methodologies, Crisis management strategy
Technologies
Six Sigma, DFR, CAPA, ISO 13485, FDA CFR 21 820
Responsibilities
Create a quality culture by driving compliance activities; Ensure quality and regulatory compliance while driving process effectiveness; Represent the company to external agencies; Execute quality objectives, metrics, and reporting; Provide informal guidance to new team members; Solve problems using technical expertise and judgment
Seniority
Senior, hands-on IC