Medical Device Complaint Specialist
Orange County Metro Area, CA
Major Accountabilities: Responsibilities will include but are not limited to:
Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
Support technical investigation of customer returned nonconforming material.
Develop and streamline complaint technical writing processes to aid in cycle time reduction.
Assist complaint intake group through review and verification of initial complaint coding.
Monitor field product performance through evaluation and trending of customer complaints and service calls. 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 as pertaining to medical devices.
Years Experience: 0-5 years
No prior experience required; however prior experience in an FDA regulated environment 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 standard;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Associate's Degree is required. Bachelor s degree in Engineering, Science, or equivalent experience and education is preferred.