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Post Market Surveillance Quality Analyst

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 201237

Description

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 Post Market Surveillance Quality Analyst will provide support to Intuitive Surgical’s Post Market Surveillance Team. Primary responsibilities include, but are not limited to, the following:

  • Ensure the complaint handling process and records meet FDA, ISO13485 and other world-wide regulatory requirements
  • Ensure quality procedures and standards are followed
  • Support departmental procedure revisions and the related document control tasks (e.g. ECOs)
  • Provide complaint handling support to the Post Market Surveillance team as needed
  • Support system enhancements and upgrades related to the complaint handling database
  • Other Post Market Surveillance activities as required to support the success of the team
 
Roles and Responsibilities:
  • Support systems and processes that Post Market Surveillance requires to manage complaints, regulatory reporting, and other related processes
  • Perform quality review of MDRs to ensure that reports are documented and reported accurately, completely, and on-time
  • Perform quality review of complaint records to ensure that records are complete and accurate and that the proper reportability decision was made  
  • Train and provide guidance to Post Market Surveillance team members regarding complaint and regulatory reporting documentation quality
  • Provide input, guidance, training and mentoring regarding complaint and regulatory reporting across the organization
  • Identify gaps in the complaint process and support implementation of corrective plans and other solutions to ensure continued compliance with applicable regulations
  • Represent Post Market Surveillance on projects as requested
  • Other tasks to support the Post Market Surveillance team in successful and timely complaint management, regulatory reporting, and meeting business goals. as needed (e.g. assess incoming complaints for reportabililty, close complaints)

Qualifications

Skill/Job Requirements:

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

  • Education:
    • B.S. or higher in Biomedical Engineering, Electrical Engineering, or Mechanical Engineering preferred
    • Non-technical degree with equivalent complex medical device experience acceptable
  • Experience/Skills:
    • Minimum 5 years relevant compliance experience working in a medical device company, regulated environment, or equivalent
    • Quality or regulatory affairs experience in a medical device company is a plus
      • Experience in US FDA Medical Device Reporting
      • Experience in OUS reporting requirements, including the European and Asia-Pacific regions
      • Auditing experience in a medical device company preferred
    • Ability to synthesize data and observations to see trends, identify gaps against regulations, and make logical recommendations for action
    • Ability to independently analyze various forms of quality data and translate into effective presentations and actionable insights
    • Independent thinker, willing to present alternative conclusions or inferences
    • Ability to influence others at various levels across the organization regarding Post Market Surveillance requirements
    • Experience in continuous improvement methodologies
    • Strong computer skills, particularly with Excel, and the ability to learn new applications; Microsoft Office Suite, SAP, TrackWise, and Agile experience preferred
    • Strong verbal and written communication skills
    • Solid interpersonal skills and able to work well with cross-functional teams and with all levels of the organization
    • Project management skills
    • Solid attention to detail, organizational skills, and extensive ability to multi-task across multiple projects/activities in a team setting
    • Must be self-directed with the ability to work independently 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.