Quality Operations Specialist

3 days ago


Reston, Virginia, United States Source One Technical Solutions Full time
Job Title: Quality Operations Specialist

Source One Technical Solutions is seeking a highly skilled Quality Operations Specialist to join our team as a consultant to a global medical device company in Irvine, CA.

Job Summary:

We are looking for a detail-oriented and organized individual to review and investigate assigned technical and clinical customer complaints. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and medical device complaint files.

Key Responsibilities:

  • Review and investigate assigned technical and clinical customer complaints
  • Perform technical investigations and document results per established procedures and timelines
  • Support quality functions pertaining to manufacturing line support and maintenance, including SAP
  • Perform hands-on troubleshooting of customer returned devices and manufacturing nonconformities and complete associated technical documentation
  • Assist complaint intake group through review and verification of initial complaint coding
  • Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections
  • Ensure that appropriate corrective actions are implemented to address the root cause of trending issues
  • Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc.)
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices

Requirements:

  • Bachelor's Degree preferred
  • Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc.)
  • Familiarity with medical device complaint files and quality records
  • Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standards
  • Strong computer skills (including Excel)
  • Demonstrated written and verbal communication skills

About Source One Technical Solutions:

We are a consulting services company that provides expert solutions to our clients in the medical device industry. Our team is dedicated to delivering high-quality services that meet the needs of our clients.



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