Hourly Rate: $30-35/hour
About this role:
Hands-on assistance will be provided by the Quality Specialist - Post Market - Temporary to guarantee that concerns are examined and evaluated promptly. Daily complaint review, investigation reports, adverse event reporting, complaints log maintenance, and trend maintenance are just a few of the responsibilities.
Our office has a fast-paced climate that promotes strong cross-functional teamwork. Above all, we are committed to providing innovations that raise the standard of medical care and enhance the patient experience. To join our team, we are seeking like-minded people who are patient and quality-driven!
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:
- 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