Customer Quality Assurance in Bothell, WA at Volt

Date Posted: 11/21/2019

Job Snapshot

  • Employee Type:
  • Location:
    Bothell, WA
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
  • Contact Name
    Volt Branch
  • Phone

Job Description

Senior Customer Quality Assurance Representative

A prominent Ultrasound Manufacturer is seeking to add to their team based in Bothell. This opportunity is a contract to hire or direct hire opportunity depending on experience and education. If you have CAPA experience, and great customer service skills please apply to schedule an interview with a recruiter!                                                                 

Principal Responsibilities:

  • Coordinates complaint intake, evaluation, and investigation activities
  • Assesses complaints for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance reporting requirements
  • Prepares and submits MDR / Vigilance reports to US and global agencies as required
  • Authorizes closure of complaints
  • Manage the intake and review of recall response forms, including trending and status updates to management
  • Escalates issues that may require corrective action
  • Generates quality data for product quality trending and improvement opportunity
  • Management of complaint, Medical Device and Vigilance Reporting Files
  • Provides training for complaint intake and returned device evaluation
  • Interacts with Customer Care to support complaint data intake requirements and complainant follow-up
  • Manages input and follow up of all Asia Pacific complaints
  • Assist in the ongoing validation of the electronic complaint handling system

Knowledge, Skills, and Abilities:

  • Education – Bachelor Degree in a scientific discipline, nursing or medical technician preferred
  • 3+ Years’ experience in Medical Device/Pharma Industry with experience in QSR, Complaint Management, Medical Device or Healthcare
  • Strong English verbal and written communication skills
  • Demonstrate strong critical thinking skills to evaluate and investigate customer complaints, determining the need for CAPA and MDR
  • Demonstrate excellent people skills including ability to probe with questions for information

To learn more about Volt, please visit: and to see more of our job postings, please visit:

Volt is an Equal Opportunity Employer.