QA Complaint Coordinator

  • location: Hatfield, PA
  • type: Contract
  • salary: $19 - $23 per hour
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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
 
responsibilities:
  • 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.
 
qualifications:
  • 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.

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