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QA Engineer

No. of Jobs : 01

Job Description
  • Bachelors/Master’s degree in various discipline of science with 2-4 years experience
  • Preparation and review of all the documentations related to ISO13485:2016,QMS, MDR2017, DCGI/CDSCO, ICMR and other regulatory bodies in India and other countries
  • Responsible for interacting with various stakeholders to ensure delivery of all regulatory and quality documentation for purpose of application to CDSCO or internal/external reporting.
  • Face the audits related to regulatory which includes internal and external audits.
  • Build a team for QA and Regularity audits.

  • Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
  • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
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