Sustaining Quality Operations
Monitor and compile reports on quality metrics
Lead and project manage various quality initiatives and processes
Provide support to product manufacturing processes, including failure analysis and defect containments
Review shipping and export documents for compliance to regulations
Perform root cause analysis and propose solutions to challenges encountered
Continuously implementing items found while interacting with manufacturing and quality processes by identifying areas of opportunity within processes and procedures to improve efficiency, effectiveness, yields, eliminate waste and overall to improve the business
Product Quality Support
Evaluate product quality by performing material (FQI, IQC, etc.) inspections 4 to 8 hours per week, as needed
Travel to local tissue harvest sites to address quality events and advise on material requirements up to 8 hours per week, as needed
Detect, report, and troubleshoot quality issues and suggest robust process improvements to drive a culture of quality
Redline MPIs and QC inspection criteria for clarification and process flow improvements.
Required Skills and Experience
Basic understanding of Quality Systems and Regulatory Compliance process including requirements for making process changes
Technical writing skills including ability to both create and review procedures
Risk management mindset to drive decisions with a risk-based approach
Good grasp of basic quality assurance/control processes and tools
Ability to have positive interactions with employees, vendors, suppliers with varied backgrounds
Understands data analysis tools and operations (e.g,. Pareto, charts, and trends)
Required Education and Training
Education: High school diploma or equivalent; minimum two years of relevant experience.
Working Conditions
Must be able to sit for extended periods of time (up to 8 hours)
Must be able to lift a minimum of 25 lbs
Must be able to traverse manufacturing and design spaces
Preferred Skills and Experience
Bachelor’s degree in engineering (prefer biomedical, mechanical or system), math, physics or other sciences.
ASQ Certification as Quality Improvement Associate and/or Quality Process Analyst
Exposure to Lean Manufacturing / Six Sigma methodologies
Basic understanding of root cause investigation process
Understanding of Risk Management techniques
Basic understanding of project management principles
Bi-lingual in English and Spanish
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal 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.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
Accommodation & Accessibility Notice
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com.
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.
