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Director, Post Market Quality

Company: Nevro
Location: Redwood City
Posted on: July 29, 2022

Job Description:

About NevroNevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally.Nevro's comprehensive HFX--- spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza -, Senza II -, and Senza Omnia--- are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach--- throughout their pain relief journey and every physician with HFX Cloud--- insights for enhanced patient and practice management.Job Summary & ResponsibilitiesThis position is responsible for leading failure investigation and complaint handling teams at Nevro. Work closely with external and internal customers on responding to field inquiries, customer complaints and regulatory agency requests. This position reports to the Vice President, Global Quality Systems.

  • Responsible for understanding the technical aspects of Nevro products, and their clinical use.
  • Responsible for analyzing failure investigation trends, complaint trends and appropriately escalating issues from customer and field personnel.
  • Responsible to provide regular updates to Nevro Senior and Executive Management on any trends or corrective actions required.
  • Ensure complaints are processed in a timely manner and that adequate investigations are performed.
  • Ensure Medical Device and Vigilance reports are filed as required.
  • Work closely with Technical Service team to ensure technical inquiries are address and/or reported as complaints in a timely manner.
  • Ensuring follow-ups are tracked, managed, and closed--out on a timely basis.
  • Coordinate with internal and external partners in ensuring end-to-end service is met (e.g., technical issues, complaint handling, etc.) and that reporting is timely and accurate.
  • Ensure compliance with Nevro procedures and applicable regulatory requirements. Participate as required in FDA and notified body inspections and internal audits.
  • Ensure CAPAs are initiated for any significant adverse trends or quality problems detected through the Complaint Handling.
  • Prepare the organization for changes in the regulatory environment including ensuring applicable patient health information is adequately protected.
  • Ensure Nevro's Periodic Safety Update Report, Post Market Surveillance report are completed in a timely manner.
  • Drive continuous improvements in the Complaint Handling workflows and organize/staff the team appropriately.
  • Other duties as assigned. Role Requirements
    • A minimum of 10 years of experience in medical device with a working knowledge of appropriate FDA and European Regulatory requirements. Active Implantable Device experience and/or FDA class Ill devices preferred.
    • Must be able to demonstrate a successful track record related to the development and implementation of Complaint Handling strategies. Familiar with complaint handling systems and proven ability to drive implementation of system improvements and assuring compliance to all applicable regulations.
    • Must demonstrate a hands-on leadership ability to create a high-performing team. Skills And Knowledge
      • Minimum of 10 years in a technical role within a medical device industry is required.
      • Minimum of a BS degree preferably in Biomedical or a closely related science. MS degree is a plus.
      • A thorough knowledge of quality systems and regulatory requirements for AMID, EUMDR, MDCG and/ or class Ill medical devices.
      • Ability to lead and manage people.
      • Ability to manage multiple competing priorities.
      • Good analytical and problem-solving skills
      • Excellent oral and written communication along with good presentation and technical writing skills
      • Ability to thrive in a fast-paced, multidisciplinary environment
      • Requires the ability to travel approximately 10% of the time throughout the United States and internationallyNevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.

Keywords: Nevro, Redwood City , Director, Post Market Quality, Executive , Redwood City, California

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