Senior Quality Assurance Specialist

3 weeks ago

Boisar, Maharashtra, India Illusion Dental Laboratory Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Illusion Dental Laboratory. As a key member of our quality assurance function, you will play a critical role in ensuring the development and delivery of high-quality medical devices.

About Us

Illusion Dental Laboratory is dedicated to delivering exceptional customer service and technical expertise in the field of dental restorations. Our commitment to excellence has earned us a reputation as a trusted partner in the medical device industry.

Responsibilities
  • Apply technical solutions to problem-solving and quality improvement projects
  • Use technical writing skills to clearly describe complex technical information
  • Analyze customer complaints, identify trends, and execute corrective actions
  • Understand and apply regulatory standards to medical devices
  • Plan, generate, test, and report on medical devices
  • Maintain and review technical files in accordance with EU medical devices regulations
  • Ensure compliance with harmonized standards and site procedures
  • Support research and development initiatives
Requirements
  • Degree in Engineering or Science
  • Minimum 3-7 years' experience in R&D/QA/RA/Compliance or Validation in a medical device environment
  • Excellent technical writing experience within a medical device environment
  • Prior experience in Risk, Clinical, and Biocompatibility an advantage
  • Familiarity with ISO 13485
  • Proficiency in USFDA, ISO 13485, ISO 9001, Product Development, CAPA, Quality Assurance, Process Excellence, Six Sigma Black Belt, Project Management, CDSCO, MDD/MDR, Clinical, PMP
What We Offer
  • A competitive salary: $80,000-$110,000 per annum
  • A dynamic and supportive work environment
  • Opportunities for professional growth and development
  • A comprehensive benefits package

We invite applications from qualified individuals who share our passion for delivering exceptional quality and service. Please submit your application, including your resume and a cover letter, to be considered for this exciting opportunity.

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