We are seeking a highly motivated individual to join us as a Assoc Quality Compliance Specialist. In this role the primary responsibilities of the job are to assist with senior team member with complaint investigation routine complaints located in Irvine, CA. This position is a remote role however the individual must be able to come on site once a month determined by management.
- Evaluate event to determine if it qualifies as a complaint
- Manage customer relationship and expectations during course of complaint investigation and resolution process.
- Assist with assessment of complaint information provided and conduct additional investigation as directed and escalate as appropriate.
- May evaluate complaints for Medical Device Reporting (MDR).
- May prepare and submit MDR reports to FDA.
- Summarize routine findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labelling and/or training materials, and formulate conclusions.
- May prepare and submit final customer correspondence.
- Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required.
- Demonstrated problem-solving , critical thinking, and investigative skills.
- Good knowledge of medical terms and human anatomy
- Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
- Ability to manage confidential information with discretion
- Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment.
- Bachelor's Degree or equivalent in related field (Med Device, Quality Assurance, Regulatory Compliance)
- 2 years experience quality compliance preferred
Please apply with your most up to date resume to be considered.