Director, Post Market Quality
Location: Redwood City
Posted on: July 29, 2022
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
- Ensure complaints are processed in a timely manner and that
adequate investigations are performed.
- Ensure Medical Device and Vigilance reports are filed as
- Work closely with Technical Service team to ensure technical
inquiries are address and/or reported as complaints in a timely
- Ensuring follow-ups are tracked, managed, and closed--out on a
- 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
- 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
- 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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