• 1 year contract opportunity - W2 (No C2C)
• Compensation: $50 - $79 /hr
• Onsite: 1266 Kifer Road, Bldg 101 (SV_B101), Sunnyvale, CA,94086

At Intuitive, 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 in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s most complex challenges.

Join us in making big leaps forward for healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.

Primary Function of Position:

This position will support ISI’s Internal and External Audits to ensure compliance to regulatory and statutory requirements. This person will support activities of Third-Party visits and inspections (Notified Body, FDA etc.) focusing on backroom audit support.

Roles & Responsibilities:

This individual must have knowledge of the various regulations and standards for medical devices including MDSAP (Medical Device Single Audit Program), FDA (US Food and Drug Administration) EU MDR 2017/745 (European Union Medical Device Regulation). The primary focus of this position will be FDA readiness and to ensure compliance with 21 CFR 820 quality management system regulations.

Day to day activities may include:

• Planning, practice and preparation to ensure the successful execution of external audits
• Collaboration with process owners, with the goal to provide coaching and direction for subject matter expert in order to remediate any gaps or opportunities for improvement
• Support the internal audit program by participating in an audit or preparing for site audits
• Root cause analysis investigations, planning for corrective and preventive actions related to internal audit findings or gaps identified in the quality management system
• Review and approve internal audit finding corrective action plans
• Perform gap assessments to changes in regulations or standards
• May include analysis of data or metrics to support the internal audit program

Skills, Experience, Education, & Training:

• Bachelors’ degree in Engineering or the Physical or Biological Sciences
• Lead auditor certified (ISO 9001) to ISO 13485
• 5 years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment.
• Min. 3 years of experience managing quality system internal audits, providing front/backroom support for FDA inspections
• Demonstrated problem-solving, and critical thinking skills
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Strong people skills with focus on negotiation and arbitration factors.
• Ability to work remote
• Flexibility to travel – 25% (primarily Sunnyvale Headquarters and North America based manufacturing locations)

Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise, who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive.

Work with an Award Winning Employer:

• Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100)
• America’s Best Midsized Employers, Forbes, 2019 (#149 of 500)
• Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019
• Top CEOs, Glassdoor, 2019 (#9 of 100)

Raise and Intuitive are Equal Employment Opportunity Employers. 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 all qualified applicants with arrest and conviction records in accordance with fair chance laws.

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