Senior Quality Engineer - 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.

• 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

• 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.

• 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

• Office, lab, production, and site travel as needed (