Quality Operations Engineer

Primary Function of Position

This position works independently to execute various quality processes including quality control maintenance calibration review boards and record-keeping. It supports compliance with regulations and procedures while achieving process metrics and maintaining high-quality output. The role involves assessing performance developing tools and improving processes to meet customer demands and organizational goals.

This is a 1 year full time direct hire temporary position for a pilot program.

Essential Job Duties

• Inspection and approval of quality processes and records
• Inspection and approval of raw materials
• Release reprocessed instruments
• Create analyze and manage resolution of equipment-related events.
• Create and approve engineering changes.
• Design tools to support maintenance and calibration activities as required
• Create or update operating procedures and work instructions to improve processes.
• Support internal and external audits.
• Perform maintenance and calibration of systems as required.
• Support other quality operations initiatives (e.g. protein verification biological indicator release etc.) as directed.

Qualifications :

Required Experience and Education

• Minimum 5 years experience in quality operations and a bachelors degree in engineering discipline or equivalent combination of education and experience

Required Knowledge Skills and Abilities

• Knowledge of process improvement principles and quality systems regulations (21 CFR 820 and ISO 13485)
• Proficient in data analytics and spreadsheet software.
• Understanding of technical drawing standards measurement techniques maintenance calibration and best manufacturing practices.
• Comfortable with all phases of product development including assembly testing debugging transfer and ongoing support especially in relation to cleaning and sterilization of Instruments and Endoscopes
• Honest thorough and self-motivated with excellent problem-solving skills.
• Excellent communication collaboration and documentation skills.
• Flexible and able to adapt to shifting priorities while working independently

Additional Information :

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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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 salary ranges are listed.

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 employeeswho 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 governments 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 employeesstart 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.

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.

Remote Work :

No

Employment Type :

Full-time