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 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 (. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed. It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here.