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Title Quality Assurance Executive
Location

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

Job Information
  • Manage and maintain compliance with the EU market MDD 93/42/EEC directive (including CE Mark applications or self-declarations via technical files) along with Team Head
  • Responsible for maintaining and ensuring that the company quality system meets US FDA, ISO 13485, and all international market medical device requirements.
  • Responsible for ensuring that products and their labeling meet all regulatory requirements (national and international)
  • Responsible for the customer feedback /complaint system
  • Responsible for evaluating rejections and generating the evaluation report.
  • Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing.
  • Audit Design history files for new products for US FDA/ISO 13485/National Regulatory compliance
  • Responsible for reviewing and establishing the company quality goals each year along with Team Head.
  • Responsible for the Documentation Control Process and Documentation Change Control Process
  • Manage sterilization records and facilitation with contract sterilizer and 3rd party validation processes
  • Responsible for quality control and a quality system for Company’s products and products that we are the legal manufacturer
  • Establish an export compliance system
  • Identifying training and development needs and designing training modules to communicate quality and regulatory requirements.
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