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QA/RA manager

3 months ago

New Delhi, India Render Wise Solutions Pvt. Ltd. Full time

Company Description

Render Wise Solutions Pvt. Ltd. is a company based in New Delhi that specializes in providing responsible and precise clear aligner solutions under the brand Rejove 32 Aligners. With a commitment to "Make in India for the World," Render Wise strives to deliver the best products, services, and solutions using state-of-the-art technology and meticulous attention to detail. The team at Render Wise brings over 100 years of professional experience in Orthodontics, Healthcare & Engineering, and is dedicated to meeting the diverse needs of its customers.


Role Description

This is a full-time on-site role for a QA/RA Manager. The QA/RA Manager will be responsible for overseeing quality control, quality assurance, and quality management processes. This includes implementing and maintaining Good Manufacturing Practice (GMP) standards, conducting quality audits, and ensuring compliance with regulatory requirements. The QA/RA Manager will also collaborate with cross-functional teams to develop and improve quality systems and processes.


Qualifications

  • Experience in quality control, quality assurance, and quality management as per ISO 13485
  • Knowledge of Good Manufacturing Practice (GMP) & ISO 13485 standards
  • Experience in quality auditing
  • Strong attention to detail and ability to maintain accuracy
  • Excellent analytical and problem-solving skills
  • Strong communication and interpersonal skills
  • Ability to work effectively in cross-functional teams
  • Experience in the medical device industry is a mandatory
  • Certification in Internal Audit for ISO 13485