Quality Assurance Specialist
hace 2 meses
At Intuitive Surgical, we're driven by a shared mission: to improve lives through minimally invasive care. By harnessing innovation and intelligent technology, we empower surgeons to push beyond limitations and redefine what's possible.
We're a pioneering leader in robotic surgery, fostering an inclusive and diverse team committed to making a difference. For over 25 years, we've collaborated with hospitals and healthcare teams worldwide to address complex challenges and advance the boundaries of medical care.
Our company is built on the efforts of talented individuals from diverse backgrounds. We believe that great ideas can come from anywhere: we strive to cultivate an inclusive culture based on diverse perspectives and mutual respect. We lead with inclusion and invest in our team members to help them grow and thrive.
Passionate individuals who want to make a difference drive our culture: our team members are guided by integrity, have a strong capacity for learning, the energy to take action, and bring diverse real-world experiences to help us think differently. We actively invest in our team members to support their long-term growth and enable us to continue advancing our mission and reaching their full potential.
Job SummaryWe're seeking a Quality Assurance Specialist to join our team. This role will be responsible for supporting manufacturing operations, product changes or new product introduction projects, failure investigation, and complex inspection and project management.
The ideal candidate will have a strong background in quality engineering, manufacturing, or a related field, with a minimum of 8+ years of experience. They will be proficient in English, have a good grasp of quality and compliance systems, and be able to learn our product and process quickly.
The successful candidate will be able to work in various project teams, communicate effectively with team members, and compile data for presentation. They will also be able to handle associate risks comfortably, bring unpleasant facts to discussion, and demonstrate a results-driven approach.
Key Responsibilities- Support manufacturing operations, including product changes or new product introduction projects.
- Conduct failure investigation and complex inspection and project management.
- Develop and apply corporate-level quality metrics.
- Support line transfers between Intuitive buildings and regions.
- Plan and direct the creation of quality standards, quality control, and quality assurance procedures.
- Ensure process compliance through the design and development of comprehensive procedures.
- Develop and implement methods and procedures for disposition of discrepant material.
- Provide support to commercial product manufacturing processes, including failure analysis and documentation review and approval.
- Perform deep technical failure analysis based on the physics of failure.
- Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
- Minimum education: bachelor's degree in electrical, mechanical, or system engineering, math, or physics. Advanced degree preferred.
- Proficient in English. Ability to communicate efficiently is a must.
- Minimum 8+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 4 years in medical device design or manufacturing environment.
- Understands Quality and compliance System.
- Understands of CFR 21 Part 820/ ISO 13485 requirements for making process or design changes.
- Has a good grasp of risk assessments (Clinical/Usability risk assessments, FMEAs, etc.).
- Able to learn the product and process quickly and assesses defects' impact to product.
- Understands root cause investigation process and able to initiate routine problem-solving investigations.
- Involved in Design and process improvement projects in the past.
- Able to review Qualification and Validation protocols.
- Understands manufacturing metrics.
- Understands basic Excel data analysis operations (e.g., Pareto, charts, and trend)
- Able to work in various project teams as the Quality SME
- Able to communicate work tasks to various project team members.
- Capable of Compiling data in format appropriate for presentation
- Personality Requirements: able to cope with changes and uncertainties; and handle associate risks comfortably.
- Ability to bring unpleasant facts to discussion, does not hold back information.
- Results driven.
- Listens and respects others.
- Demonstrates constructive work relationship with others in the organization.
- Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues.
Intuitive Surgical is an equal opportunity employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit any form of discrimination and harassment, regardless of race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran status, or disability, genetic information, or any other protected characteristic under applicable federal, state, or local laws.
Shift: Day
Travel: 25% of the time
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