Senior (Quality Engineer 4) - Endoluminal Systems

Primary Function of Position
This role oversees end-to-end quality investigations (spanning on-site manufacturing operations, supplier operations, product design activities and customer complaints), risk management, new product development and BU wide improvement initiatives across the Endoluminal product family and operational area.
Essential Job Duties
Leads critical product, process investigations and audits with cross functional and cross site impact.
Identifies systemic quality issues and drives sustainable solutions.
Ownership of quality investigations for complaints and non-conformances.
Serves as escalation owner for medium to high impact product quality & compliance risks
Author, review, and approve QA documentation and protocols.
Drive and own corrective and preventive action (CAPA) and/or Process NCs
Ownership of risk assessment activities and process reviews.
Support regulatory and customer audit preparations and responses.
Analyze and interpret advanced quality data and KPI trends.
Mentor junior engineers and technicians in technical expertise.
Ensure compliance with company and regulatory standards (GMP, ISO, FDA).
Advise cross-functional teams on quality requirements.
Indentification and ownership of continuous improvement projects.
Breadth of Impact and Leadership
Owns quality outcomes across a product family, plant, or major operational area
Drives improvements that impact multiple teams or value streams
Leads cross functional teams without authority
Mentor/coach junior QEs to transform into independent owners
Influences decisions through expertise and credibility
Required Experience and Education
Minimum 8 years of experience in QE/QA and bachelor’s degree in a engineering or relevant discipline, or equivalent combination of education and experience.
At least 2 years of experience in a regulated industry in a relevant discipline.
Required Knowledge, Skills and Abilities
Experience in supporting NPI from design and development through to manufacturing transfer
Demonstrated experience supporting mechanical assembly of electro-mechanical systems, including supporting multi-component assembly processes.
Skilled in designing and implementing inspection at upstream and downstream stages to early and appropriate detection
Strong understanding of quality principles and methodologies
Strong data analysis and data interpretation skills
Strong ability to drive and resolve quality issues
Strong communication and team collaboration, ability to influence stakeholders across departments
Physical Requirements
Office, lab, production, and site travel as needed (<10%).
Frequent computer and inspection work.
Occasional lifting (<25 lbs) and PPE for production or regulated areas.

Employment type
Full-time

Work arrangement
Hybrid