QA Regulatory Specialist - Medical Devices

Summary of Position:

• We are looking for a detail-oriented Quality Assurance Specialist to be in charge of all quality assurance activities.
• The Quality Assurance Specialist's responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.
• A QA Specialist is responsible for quality assurance audits and ensures product integrity and that standards are being met. A good QA specialist will know how to troubleshoot systems to ensure reliability, usability, and performance.
• To be successful as a Quality Assurance Specialist you should be incredibly thorough and able to help our
• The company maintains the highest quality standards.
  
  

Essential Duties and Responsibilities:

• Prepare and implement quality assurance policies and procedures.
• Perform routine inspections and quality audits.
• Identify and resolve workflow and production issues.
• Ensure that standards and safety regulations are observed.
• Address and discuss issues and proposed solutions with superiors.
• Document quality assurance activities and creating audit reports.
• Make recommendations for improvement.
• Create training materials and operating manuals
• Handle Non-Conformity Reports.
• Define root causes in CAPA and NC Reports.