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.

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