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Lead Quality Assurance Engineer
2 months ago
At Intuitive, we are driven by our mission: we believe that minimally invasive care is transformative for patients. Through innovation and advanced technology, we enhance the capabilities of healthcare professionals to deliver care without limitations.
As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce, committed to making a positive impact. For over 25 years, we have collaborated with healthcare providers globally to tackle some of the most challenging issues in healthcare and push the boundaries of what is achievable.
Intuitive thrives on the contributions of talented individuals from various backgrounds. We believe that great ideas can emerge from anywhere. Our aim is to create an inclusive environment that values diverse perspectives and mutual respect. We prioritize inclusion and empower our team members to perform at their best as their authentic selves.
Our culture is fueled by passionate individuals who seek to make a difference. Our team members are grounded in integrity, possess a strong willingness to learn, demonstrate the energy to accomplish tasks, and bring a wealth of real-world experiences that help us innovate. We actively invest in our team members to support their long-term development, enabling them to further our mission and reach their full potential.
Join a team dedicated to making significant advancements for a global community of healthcare professionals and their patients. Together, let's elevate the field of minimally invasive care.
Position Overview
Primary Responsibilities
This role oversees the Quality Engineering team within the Single Port Business Unit, focusing on upholding and promoting product quality. The manager will lead an organization that collaborates across the company, acting as champions for the Product Quality mission.
Key Duties
Lead New Product Introduction and Quality Operations for DaVinci Single Port (SP) Instruments, Accessories, and Endoscopes. Responsibilities include:
- Provide quality engineering support for product-related challenges arising from manufacturing, utilizing appropriate quality notifications; ensure the adequacy of product impact assessments, dispositions, and escalation outcomes.
- Drive continuous improvement initiatives by performing trend analysis on reported manufacturing quality notifications and/or post-market complaints.
- Oversee the evaluation of product failures and/or non-conformances; establish metrics and promote product and/or process improvement opportunities; manage failure investigations, review engineering assessments, and support projects addressing these failures; identify and track improvement metrics.
- Collaborate with senior leadership and cross-functional teams to define strategies, priorities, and objectives for complaint reduction, cost of poor quality, trend analysis, process validation, statistical quality, and process control.
- Provide expertise in change assessments (product and process), process validations, statistics, risk-based sampling, and measurement system analysis.
- Partner with manufacturing teams to transition products and processes into the production environment with high quality and support these products throughout the production phase.
- Evaluate the necessity for escalations regarding identified quality issues and assist team members in conducting escalation assessments and implementing necessary corrective and preventive actions.
- Manage the Quality Engineering team; assess skills, conduct gap assessments, prioritize team development; lead talent acquisition and budgeting efforts.
- Accountable for departmental and team member goal setting, tracking, adjustments, and recognition as appropriate.
- Represent quality management at monthly and quarterly review meetings (Quality Data & Operations Review).
- Establishing data-driven priorities for the continuous enhancement of Intuitive's products and processes.
- Ensuring quality, reliability, and safety are integral to Intuitive's product design by collaborating with Design Engineering, Manufacturing Engineering, and Supplier Quality.
- Guaranteeing data quality and process quality for anything affecting Intuitive's product or patient outcomes, including the improvement of SOPs, DOPs, etc.
- Generating risk assessments for products in the field, including recall assessments (in conjunction with Regulatory Compliance).
- Supporting in-depth technical failure analysis, root cause analysis, resolution, and prevention for complex quality issues.
Skills, Experience, Education, & Training:
- Strong understanding of medical device manufacturing operations and risk-based quality approaches.
- Education: Engineering or Physics with a master's degree or equivalent experience.
- Minimum of 8 years of experience, with at least 5 years in quality management within a complex medical device environment, or equivalent quality background; minimum of 1-3 years of experience in a managerial role.
- High integrity and a strong desire to foster a collaborative work environment.
- Proven ability to build, support, and manage teams, and to lead cross-functional projects.
- Demonstrated analytical skills with a track record of addressing and resolving complex product and process issues.
- Training or equivalent experience in quality science.
- Proven capability to drive and motivate teams across functional boundaries.
- Ability to navigate conflicting requirements and make difficult trade-offs when resources are limited.
- A commitment to performing essential tasks efficiently and effectively.
- Excellent judgment in the face of competing priorities and incomplete information.
- Travel requirement for this position is 10%.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require proof of vaccination against certain diseases, including COVID-19. Details may vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information, or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We offer market-competitive compensation packages, including base pay, incentives, benefits, and equity. Actual pay will be determined based on several factors, including experience, skills, and qualifications.
