QUALITY ASSURANCE ASSOCIATE/ Medical Device

Our client is a medical device company dedicated to offering innovative solutions for treatment of chronic heart failure. The Company’s developments are based on its proprietary technology for administrating Cardiac Contractility Modulation therapy.

• Write and review of SOPs and other quality assiuance related technical data forms and quality documents
  
• proper maintenance of control documents in Quality Assurance
• Control documents to differents departments
• Review validation protocols for GMP compliance
• Assist in carrying out internal quality audits on company systems and documentations
• perform investigations on non-conformances and customer complaint close out and corrective actions
• Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines
• Provide GCP/ QA support and avdvice to internal and external clients
• Ensure the timely and effective follow up  to all identified or assigned quality issues
• Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to include but not limited to ISO13485, 21FR; part 820 AIMD
• Assist in the maintenance ogf Quality Management System under direction of Director, Quality Assurance
• Participate in Mock inspections for FDA inspection preparation

Ability to work independently with little or no supervision

Exeptional oral and written communication capabilities

Advance computer knowledge in MS Office programs

Bachelors's Dregree in related field

4-6 years  related experience

Experience working in regulated environment with medical devices

Experience with FDA inspections and /or Notified Bodies Audits desirable

All your information will be kept confidential according to EEO guidelines.