QA Complaint Coordinator

  • location: Hatfield, PA
  • type: Contract
  • salary: $19 - $23 per hour
easy apply

job description

QA Complaint Coordinator

job summary:
This position will support the Quality, Regulatory, Operations, and Engineering departments by managing all open complaints, escalating Out of Box failures and suspected Adverse Events/MDR's to the appropriate teams, and providing routine and ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities.

location: Hatfield, Pennsylvania
job type: Contract
salary: $19 - 23 per hour
work hours: 9 to 5
education: High School
  • Review new complaint notifications to ensure that the correct status was assigned, and coordinate with Technical Support personnel for any changes that are needed.
  • Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR's.
  • Manage complaints to ensure that they are closed within process timeframe.
  • Obtain Device History Records as required to support investigations.
  • Prepare and publish routine and ad hoc external defect reports by product family.
  • Create Pareto charts and assist in data analyses for Root Cause investigations for reliability improvement projects, Verifications of Effectiveness, and similar activities.
  • Maintain Daily Management boards for the Customer Defect Tracking & Resolution process.
  • Continuously improve processes to further streamline and automate complaint data processing.
  • High school diploma or equivalent plus 3 years of experience working in a quality assurance, medical device and/or manufacturing setting or Associate degree plus 1 year of experience working in a quality assurance, medical device and/or manufacturing setting
  • Demonstrated ability to communicate effectively, both verbally and in writing
  • Must have basic computer skills, including proficiency in Microsoft Office software
  • ERP, SAP and QMS (Master Control) experience
  • Strong interpersonal and communication skills, self-organization, and ability to work with minimum supervision
  • Knowledge of GMP and Quality Systems in a regulated industry (medical device or pharmaceutical area)
  • Ability to follow written documented procedures
skills: Quality Assurance, GMP (Good Manufacturing Practice), ERP System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

easy apply

get jobs in your inbox.

sign up

related jobs

    Associate Scientist

  • location: Exton, PA
  • job type: Contract
  • salary: $23 - $25 per hour
  • date posted: 9/28/2020