Quality Engineer 3 - Endoluminal Systems

Primary Function of Position
This role independently owns quality projects and initiatives, investigations, inspections and improvement activities within the Endoluminal product platform. The role will span design, manufacturing and service of a selected product or sub-system.
Essential Job Duties
Independently owns product, process and complaint investigations within the Endoluminal product family
Serves as escalation owner for low to medium impact product quality risks
Review and maintain test records and reports for completeness and accuracy
Own, drive and/or participate in CAPA and systemic Process non-conformances
Assist in updating and revising QMS documentation
Leads risk assessment activities and process reviews
Analyze and present data for trends in defects and report out to peers at an established cadence
Ensure compliance with company and regulatory standards (GMP, ISO, FDA)
Be an integral member of a project Core Team and contribute meaningfully to the project’s success
Communicate findings and recommendations to stakeholders
Ownership of continuous improvement projects with various levels of scope (Business Unit/Org/Team)
Breadth of Impact and Leadership
Owns quality outcomes for a product or defined subsystem.
Recognized as a reliable QE partner by cross-functional product team.
May mentor/coach junior level QEs on tools, processes and investigations.
Leads small initiatives
Required Experience and Education
Minimum 5 years of experience in QE/QA and bachelor’s degree in an engineering or relevant discipline, or equivalent combination of education and experience.
Required Knowledge, Skills and Abilities
Solid understanding of quality principles and methodologies
Solid data analysis and data interpretation skills
Identify and resolve quality issues independently
Strong communication, presentation and team collaboration.
Staying updated with evolving standards, tools and technologies
Physical Requirements
Travel <10%
Frequent computer and inspection work.
Occasional lifting (<25 lbs) and PPE for production or regulated areas.

Employment type
Full-time

Work arrangement
Hybrid