Senior Quality Assurance Specialist

1 day ago


Hyderabad, Telangana, India beBeeEngineering Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title:

Job Description

The ideal candidate will possess a strong background in quality management, with experience in medical device QMS processes. They will be responsible for fostering a culture of excellence by driving compliance activities and ensuring quality and regulatory compliance.

  • Develop comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process-related documentation.
  • Establish a culture of compliance by driving activities around specific products, sites, or regions.

The candidate should possess excellent communication skills, both written and oral, and be able to effectively communicate technical information in English. They should also have experience in establishing design quality control, assurance, regulatory affairs teams & competence development from scratch within a regulated industry.

Required Skills and Qualifications:

  • Mechanical Engineering expertise in Medical Devices Design Controls, Quality Management System, Standards & Regulations, such as ISO 13485, 60601, 14971, etc.
  • Electrical & Electronics Hardware Engineering, including Embedded Hardware Engineering expertise.
  • Software Engineering expertise.
  • Systems Engineering expertise.

Benefits:

This role focuses on executing the organization's strategy, providing clearly defined success criteria and levels of accountability for individuals in the team. Removes impediments for the progress of the teams and acts as an escalation point.

Others:

Being a Technical, Hands-on Subject Matter Expert in the field of Systems Engineering. Audit support for products for various regulatory agencies, customer satisfaction by providing faster engineering resolution to issues faced by customers.



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