We are excited to partner with an industry leading biomedical device company in Cincinnati, in business for 75+ years, in search of a Quality Coordinator-CAPA Analyst to add to their growing team. Our client has a fantastic culture, team environment and competitive compensation package!
YOUR ROLES AND RESPONSIBILITIES
- Responsible for the compliance and execution of the following QMS processes:
- Corrective & Preventive Action Procedure
- Supplier Corrective Action
- Provides support to the following QMS processes:
- Complaint Investigations
- Risk Management
- Strong knowledge of current standards, procedures and regulations with emphasis on: ISO13485, 21CFR 820, EU Medical Device Directive and Canadian Medical Devices Regulations.
- Ability to conduct analysis of data, organize information, and produce reports based on provided instruction.
- Bachelor’s Degree or equivalent work experience.
- A minimum of five (5) years of quality or regulatory affairs/compliance experience, preferably within the medical device or pharmaceutical industry, or a medical/healthcare related field (equivalent combination of education, experience, and training considered