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Quality Assurance Compliance Specialist

3 months ago

Billerica, United States Phaidon International Full time

EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable The work would involve experience working with systems such as Trackwise, Veeva or QMS.



Duties and Responsibilities:

  • Investigates complaints to determine complaint cause, completes Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
  • Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports



Skills and Knowledge:

  • Bachelor’s Degree
  • Minimum of 2 years of experience in Quality Assurance with complaint processing role.
  • Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
  • Must demonstrate the ability to investigate complaints with minimal guidance.
  • Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
  • Understand basic principles of good technical writing skills
  • Excellent communication (verbal and written) and interpersonal skills required
  • Deep Knowledge of Trackwise
  • Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
  • Deep knowledge of Quality Systems (CAPA/non-conformances/SCARS)



Please send over your up to date resume and any relevant references


Kind regards,

Marcel