Nevro Corp.

Sr. QA Compliance Specialist (Temporary)

US-CA-Redwood City
2 weeks ago(1/5/2018 2:47 PM)
ID
2018-2024
Category
Quality

About Nevro

Nevro is a medical device company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform for the treatment of chronic pain.

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 advanced the state of spinal cord stimulation (SCS).

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.

Overview

JOB SUMMARY

 

The Sr. QA Compliance Specialist is responsible for providing subject matter expertise in quality assurance activities such as internal audits, CAPA, External References Control, Complaint Handling, MDR and Vigilance reporting. 

 

Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports complaint handling in internal and external audits and inspections

Role Requirements

ESSENTIAL DUTIES & RESPONSIBILITES

  • Ensure complaint investigations are adequate, accurate, detailed and timely.
  • Analyze events reported from multiple inputs to determine complaint status and regulatory reportability.
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
  • Complete submission of MDRs to the FDA, electronically if applicable.
  • Ensure accurate data entry, scanning, and retention of documents to complete event files.
  • Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.
  • Ensure complaint investigations are adequate, accurate, detailed and timely.
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
  • Ensure audit results are formally recorded and reported and corrective and preventive actions are documented.
  • Responsible for managing CAPAs, SCARs. Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness. Elevate issues to management as appropriate.
  • Write and maintain SOPs, WI’s, audit reports and other documentation as required.
  • Identify, generate and publish metrics and reports related to the Quality issues.
  • Responsible for maintenance of external standards.https://nevro.icims.com/icims2/servlet/icims2?module=AppProfileEdit&action=switchEditTab&hashed=989343898&type=next#!
  • Drive continuous improvement of the Quality System.
  • Performs other duties as required

Skills and Knowledge

EXPERIENCE

  • 4 year technical or science degree or equivalent relevant experience
  • 8+ years of Quality/Regulatory experience in a medical device or other regulated industry and 4+ years of experience in reporting adverse event preferably in AIMD
  • Experience with complaint handling, MDR/Vigilance reporting

SKILLS & KNOWLEDGE

  • Can work independently in a team environment
  • Takes initiative and proactively seeks quality solutions through continuous improvement
  • Knowledge of 21 CFR Part 820, Quality System Regulations
  • Knowledge of 21 CFR Part 803, Medical Device Reporting
  • Effective priority setting
  • Excellent written and oral communication skills along with good presentation and technical writing and be able to work in a team environment or independently
  • Must have good analytical and problem solving skills
  • Working knowledge of Microsoft Office applications

#LI-GR1

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.