Intuitive Surgical Careers

Indirect RA/QA Project Manager

US-CA-Sunnyvale, California
Engineering


Job Description

Job: Engineering
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 190648

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 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 licenses
o Regulation changes
o Alignment with QMS requirements
o Standardization of documentation and templates
o Cross functional process improvements
o Indirect QA audits and finding management
o 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

Qualifications

Skill/Job Requirements:

Minimum requirements in order to adequately perform the responsibilities of this position 

• Education:
o B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
o Non-technical degree with equivalent complex medical device experience acceptable
• Experience/Skills:
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 regulations
o Auditing exposure or experience in a medical device company preferred
o Ability to independently analyze various forms of data provide actionable output
o Ability to synthesize data and observations to see trends, identify gaps against regulations and make logical recommendations for action
o Independent thinker, willing to present alternative conclusions or inferences
o Ability to understand detailed technical information such as engineering drawings / specifications / etc.
o Ability to influence others cross organizationally at various levels
o Experience in continuous improvement methodologies
o Strong computer skills, particularly with Excel and the ability to learn new applications, Microsoft Office Suite, SAP & Agile experience preferred
o Strong verbal and written communication skills, proven ability to translate analytical information into effective presentations
o Good interpersonal skills and able to work well with cross-functional teams
o Good project management skills
o Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting
o 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.