Quality Specialist - Post Market
Hourly Rate: $30-40/hour
About this role:
The Quality Specialist - Post Market - Temporary will offer direct support to ensure that issues are looked into and assessed as soon as possible. A few of the duties include reviewing complaints on a daily basis, maintaining complaint logs, investigating reports, reporting adverse events, and maintaining trends.
The fast-paced environment of in our office fosters great cross-functional teamwork. Above all, we are dedicated to offering innovations that improve patient care and increase the bar for medical treatment. We are looking for patient, quality-driven, like-minded individuals to join our team!
The Quality Specialist - Post Market position will be responsible for:
- 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.
The Quality Specialist - Post Market position should have the following requirements:
- 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
