Intuitive Surgical Careers
Senior Compliance Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183044
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.
Senior Compliance Engineer/Specialist will provide expertise and support to run efficient, effective and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. S/he 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 help educate the organization on effective compliance systems and processes in order to meet corporate, national and international standards.
S/he will work with cross functional organizations (Quality Systems, Product Quality, Engineering, Post Market Surveillance, Service, Customer support etc.) as the Compliance representative and provide support on projects ranging from product issues/escalations, corrections, corrective and preventive actions, facility moves, changes to standards/regulations, internal/external audit support and management of the health of the overall quality system.
Roles and Responsibilities:
• Additional responsibilities include but not limited to:
• Help provide guidance on a variety of ad-hoc compliance questions, including helping research the regulations, current process/practices within ISI, industry/regulatory agency expectations etc.
• Provide guidance, review and approve various documents on behalf of Reg. Compliance, ranging from customer facing materials, technical bulletins, QS procedures, facility moves and establishment registrations etc.
• Establish and prepare Quality Review Board metrics for the Regulatory Compliance group.
• Help coordinate Quality Review Board and Management Review meetings, work with cross functional teams to coordinate/summarize the data, key take–aways and actions
• Provide support to the audit team during audits and inspections, help with audit preparation, hosting, front/back room support
• 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.
• Bachelor’s Degree in a scientific or other relevant field is preferred.
• 6+ years of experience in Quality, Compliance or Regulatory role in the medical device industry is required.
• 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 QSRs, cGMP, ISO 13485, ISO 14971, European Medical Device Directive, Canadian Medical Device Regulations (CMDR) etc.
• Ability to understand complex medical devices and regulations in the space of Capital Equipment, Disposable and Reusable product lines, Software Controls, Electrical Safety, wireless technology, RFID, etc.
• 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
• Ability to work with highly technical teams and effective communicate in an engineering driven team environment
• 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.