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Quality Coordinator-CAPA Analyst-Medical Devices

Cincinnati, OH
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
 
QUALIFICATIONS/SKILLS
  • 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.
 
EDUCATION/EXPERIENCE
  • 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
 
Apply Today!
 
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