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:
- A bachelor's degree
- A minimum of two years' experience handling complaints in a quality assurance capacity.
- Prior medical device experience and functional understanding of ISO 13485, FDA 21 CFR 820, and EU MDD/MDR
- Must exhibit the capacity to look into concerns with little direction.
- 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
- Timeliness and attention to detail are essential
Responsibilities:
- 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.
- Conducts and/or arranges the investigation of complaints and the acquisition of supplementary data, collaborating closely with other departments to finalize investigative reports.
- Conduct a technical review of all the data to guarantee proper analysis and investigation
- Maintains a complaints log; reviews daily procedures to make sure issues are addressed and escalated promptly; takes part in process improvements
- Performs other tasks relating to quality and regulations as delegated
