Senior (Quality Engineer 4) - Endoluminal Systems

Job description

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

Qualifications

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 ( Frequent computer and inspection work.

Occasional lifting (