Nevro Corp.

Quality Intern

US-CA-Redwood City
4 weeks ago(12/21/2017 6:44 PM)
ID
2017-2010
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 States.

 

Overview

This position is responsible for maintenance of Quality Records and Standards. This position is also responsible for providing support to the Quality team in managing documents related to QMS, BOM, DHF, ECOs, Supplier Files, templates for Design Control etc. This position works directly with Quality.

 

  • Organize documents in QMS for transition to PLM system:
    • Assess the files and put them in to categories/ Types for PLM system
    • Identify the Part files that has Supplier drawings. Organize them for engineering review and place Change Request for any documents required to be obsolete.
  • Create BOM structure by product catalog numbers, including alternate BOM structures
  • Identify PN by Suppliers
    • including Nevro PN/supplier PN/supplier Doc Number and revisions at different CMs as applicable
  • Organize the DHF along with Supplier ECOs
  • Assist QE in updating the standard list and review and update compliance checklist, technical file
    • Assist QE with generation of any gap analysis file.
  • Supplier files and supplemental supplier file cleanup and update as necessary
  • Assist QE in generating controlled templates related to Design Control
  • General filing and organizing quality records

Role Requirements

  • All candidates are required to be working towards a four (4) year Bachelor’s degree to be eligible for this program or part of an MBA program.
  • Knowledge of medical device regulations is helpful.
  • Experience in biotech and/or the device industry recommended

Skills and Knowledge

  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate and summarize technical data.
  • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.
  • Excellent problem solving and analytical skills.
  • Good written and oral communication skills.
  • Detail-oriented, methodical and able to handle quality information with a high degree of accuracy.
  • Complete work with minimal supervision and ability to work independently.
  • Knowledge of medical device regulations.

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