Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Irvine, CA.
Title: Quality Operations Specialist I (Complaint Investigator)
Pay Rate: $36/hr (W-2)
Contract Length: 12 months with possible extension
Major Accountabilities:
• Review and investigate assigned technical and clinical customer complaints.
• Perform technical investigations and document results per established procedures and timelines.
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes 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
