Quality Engineer 3 - Endoluminal Systems

Job description

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

Qualifications

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 Frequent computer and inspection work.

Occasional lifting (