We have an immediate need for a QA/RA Specialist with a medical device company in Kennesaw, GA. This is a direct hire opportunity with a salary and benefits. The QA/RA Specialist will assist in completing various quality and regulatory tasks relevant to medical device manufacturing and distribution.
- Assist in preparation for applicable FDA, ISO, and internal audits.
- Maintain training files for employees.
- Develop and track relevant fiber manufacturing Quality Management metrics.
- Perform CAPA activities (i.e. review proposed corrective actions, effectiveness checks).
- Assist in updating documents through redline, DCO administration, document receipt/verification tracking and applicable personnel training relative to document changes.
- Serve as CAPA Administrator and assist in complaint handling processes including file maintenance, complete complaint investigations, complaint trending and complaint file closure.
- Bachelor’s degree in Biomedical or Mechanical Engineering, Business or related area.
- 2+ Years of experience within the medical device industry.
- Knowledge of quality tools/sampling plans/problem solving/statistical process control/design of experiments.
- Knowledge of ISO 13485:2016 and/or FDA 21 CFR 820 experience
- Relevant experience in Quality Assurance, Regulatory Affairs, Compliance or Development in an FDA regulated environment.