Sr Quality Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.

Roles & Responsibilities:

• Develop, implement, maintain and improve appropriate quality system elements to ensure a degree high product quality and continuous improvement.
• Provide Quality Engineering support for, NPI, Sustaining activities and improvement projects.
• Own and/or support Quality Notifications (Non-Conformance events), Correction and Preventive Actions (CAPA) as needed and assigned.
• Assess Manufacturing and Design changes against their impact and support the implementation of such changes.
• Support Post Market in the analysis of Complaint data and RMAs Failure Analysis investigation.
• Collect, analyze, and trend product quality data and provide reports to management on progress or escalation.
• Author test protocols/reports (MVPs, IQ/OQ/PQ, Engineering reports) and execute qualification and validation testing as needed.
• Address product quality issues and approve material dispositions.
• Support Internal and External audits.
• Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
• Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner
• Apply knowledge of process control tools, statistical sampling and other analytical techniques to maximize the quality and flow of product through the production line.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.
• Troubleshoot equipment, process or material issues and provide resolutions.
• Support projects to support the site manufacturing and quality improvement initiatives.
• Performs other duties assigned as needed.

Qualifications

Skills, Experience, Education, & Training:

• Minimum Education: 4-year degree in STEM. Engineering degrees are preferred.
• 6 years of related work experience in a regulated industry or a minimum 4 years with a master’s degree.
• Preference for Electro-Mechanical Medical Device experience
• Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e., Root Cause Problem Solving).
• Ability to apply project management skills to ensure fulfillment of new product development requirements.
• Ability to develop and implement Quality standards.
• Demonstrated auditing and problem-solving skills.
• Strong knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
• Ability to effectively communicate with internal and external personnel at all levels of the organiz