Design Quality Assurance Engineer III - Endoscopy
Core
Leading complex design-related nonconformance (NCEP) and CAPA activities to ensure safety, quality, and compliance of medical products across the product lifecycle.
Role type
Senior Design Quality Assurance Engineer
Builds
Medical devices (Endoscopy Division)
Domain
Medical Devices / Regulatory Quality
Required skills
Root cause analysis (5 Whys, Is-Is Not, DMAIC, Six Sigma), Design Controls, CAPA management, Regulatory compliance, Cross-functional leadership, Mentoring, Process improvement, Audit support
Responsibilities
Lead and provide quality oversight for complex design-related NCEP/CAPA activities; Leverage technical knowledge to lead teams through complex investigation and problem-solving initiatives; Partner with cross-functional teams to develop risk-appropriate corrective and preventive actions; Provide quality and compliance input to project teams for project decisions and deliverables; Guide and mentor engineers on quality engineering methodologies; Act as the primary voice for quality within cross-functional teams; Identify and implement best-in-class practices for the department; Support internal and external regulatory audits as required.