Director, Post Market Quality
Nevro (NYSE: NVRO) is a public multinational medical technology company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform.
We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 28,000 patients around the world.
The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.
Responsible for leading technical services and complaint handling teams at Nevro. Work closely with internal and field personnel on responding to technical inquires and addressing customer complaints.
This position reports to the Vice President, Quality.
- Responsible for understanding the technical aspects of Nevro products, and their clinical use.,
- Responsible for monitoring and coaching of Technical service personnel and ensuring they are adequately trained to respond to technical inquires from Nevro field personnel, Nevro patients, physicians and health car providers.
- Responsible for analyzing trends and appropriately escalating issues from customer complaints or unresolved technical issues. Provide regular updates to Nevro Senior Management on any trends or corrective actions required..
- Ensure complaints are processed in a timely manner and that adequate investigations are performed and that Medical Device and Vigilance reports are filed as required.
- Ensuring follow-ups are tracked, managed, and closed-out by technical service reps 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 Technical Services or Complaint Handling teams.
- Prepare the organization for changes in the regulatory environment including ensuring applicable patient health information is adequately protected.
- Ensure Nevro’s Post Market Surveillance reports are completed in a timely manner..
- Drive improvements in the Technical Services and Complaint Handling workflows and organize and staff the team appropriately.
- 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 III devices preferred.
- 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 and/ or class III medical devices
Skills and Knowledge
- Must be able to demonstrate a successful track record related to the development and implementation of Technical Services and 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.
- 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 internationally