Sr. Quality Operations 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

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 bachelor's 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 det