Intuitive Surgical Careers

Senior Compliance Engineer

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 190104

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function:

The Sr. Compliance Engineer will support ISI’s Internal and External Audits to ensure compliance to regulatory and statutory requirements. This person will support all activities of Third Party visits and inspections (Notified Body, FDA etc.). The Sr. Compliance Engineer will ensure overall Quality Management System (QMS) compliance and ensure an up-to-date understanding of applicable laws and regulations so that the company’s risks are identified and managed appropriately. S/he will lead and educate the organization on effective compliance systems and processes in order to meet corporate, national and international standards.

Roles and Responsibilities:

Responsibilities of the Sr. Compliance Engineer include, but are not limited to the following:

• Facilitate and ensure the successful execution of certification and surveillance audits
• Provide support, expertise, and direction to all ISI sites during regulatory audits and inspection
• Lead efforts to prepare responses to regulatory audit observations. Ensure that responses are clear, comprehensive, accurate, and well-written to mitigate potential for further regulatory actions.
• Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. Help track and trend data on common areas of vulnerability.
• Work with a cross function team to lead the remediation efforts and ensure resolution.
• Lead implementation and continuous improvement of the audit programs, auditor qualification programs, company-wide inspection readiness.
• Work with global teams on facility moves and establishing new sites, to provide guidance on the necessary actions, including establishment registrations, updates to Quality Systems and ISO Certificates.
Qualifications

Skills/Requirements:

• Bachelors’ degree in Engineering or the Physical or Biological Sciences recommended.
• 6+ years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment.
• Min. 3 years of experience managing audits, providing front/back room support
• Ability to understand the regulations and help interpret it for the company. Working knowledge of implementing, and providing guidance on domestic and international regulations.
• Applied understanding of QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive, and Canadian Medical Device Regulations (CMDR)
• Ability to be a true team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions.
• Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment



We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.