Quality Specialist - Post Market
Hourly Rate: $30-35/hour
About the Role:
A small to mid-sized pharmaceutical company in Orange County is looking to add a Quality Specialist - Post Market professional to maintain their status as a top organization of digital health care. The clients main focus is to utilize data trends to improve the lives of millions worldwide. The organization is seeking like-minded individuals who are patient and quality-driven while working the on-site position. Additional details about the position are below:
Requirements:
1. A bachelor's degree
2. A minimum of two years' experience handling complaints in a quality assurance capacity.
3. Prior medical device experience and functional understanding of ISO 13485, FDA 21 CFR 820, and EU MDD/MDR
4. Must exhibit the capacity to look into concerns with little direction.
5. Excellent critical thinking abilities, ability to solve problems, and background in researching and handling complicated problems and possess a foundational understanding of technical writing techniques
6. Timeliness and attention to detail are essential
Responsibilities:
7. Assesses complaints to determine whether to proceed with a complaint inquiry, as well as medical device and Vigilance Reporting in compliance with European Vigilance Reporting and 21 CFR Part 803.
8. Conducts and/or arranges the investigation of complaints and the acquisition of supplementary data, collaborating closely with other departments to finalize investigative reports.
9. Conduct a technical review of all the data to guarantee proper analysis and investigation
10. Maintains a complaints log; reviews daily procedures to make sure issues are addressed and escalated promptly; takes part in process improvements
11. Performs other tasks relating to quality and regulations as delegated