Intuitive Surgical Careers
Indirect RA/QA Project Manager
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 190648
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 of Position:
The Indirect RA/QA Project Manager will provide regulatory and quality directive support for all indirect (distributor) regions. Primary responsibilities include process maintenance and improvements, audit readiness, maintenance of applicable systems, and other regulatory affairs, regulatory compliance or quality assurance activities.
Roles and Responsibilities:
• Provide input, guidance, training and mentoring related to Regulatory Affairs, Compliance, and QA specific to the indirect market.• Lead and organize project teams to drive focused results and projects related to
o Indirect submissions (new or revisions)o Maintenance of submissions and licenseso Regulation changeso Alignment with QMS requirementso Standardization of documentation and templateso Cross functional process improvementso Indirect QA audits and finding managemento Others as needed
• Accomplish project objectives by planning and evaluating project related activities and communicating status and project to management on a regular basis• Contribute information and recommendations to strategic plans• Prepare and complete action plans to implement productivity, quality, problem resolving, identifying trends, determine system improvements, and implement change• Enhance department and organization reputation by accomplishing requests, exploring opportunities and adding value to job accomplishments• Develop tools and best practices• Lead task teams for cross functional projects• Establish, prepare, analyze and metrics• Develop relevant procedures in support of continuous improvement in the Quality Management System• Participate as the Indirect RA/QA representative on other projects as requested or needed
Minimum requirements in order to adequately perform the responsibilities of this position
o B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferredo Non-technical degree with equivalent complex medical device experience acceptable
o Minimum 5 years relevant experience working in a medical device company, regulated environment or equivalent
• Quality or regulatory affairs experience in a medical device company a plus
o Expertise in global regulationso Auditing exposure or experience in a medical device company preferredo Ability to independently analyze various forms of data provide actionable outputo Ability to synthesize data and observations to see trends, identify gaps against regulations and make logical recommendations for actiono Independent thinker, willing to present alternative conclusions or inferenceso Ability to understand detailed technical information such as engineering drawings / specifications / etc.o Ability to influence others cross organizationally at various levelso Experience in continuous improvement methodologieso Strong computer skills, particularly with Excel and the ability to learn new applications, Microsoft Office Suite, SAP & Agile experience preferredo Strong verbal and written communication skills, proven ability to translate analytical information into effective presentationso Good interpersonal skills and able to work well with cross-functional teamso Good project management skillso Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team settingo Must be self-directed with the ability to work with minimal supervision
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.