Design Quality Assurance Specialist

1 week ago


Reston, Virginia, United States Intellectt Inc Full time

Job Title: Design Quality Assurance Specialist

Location: Not specified

Duration: Not specified

Key Responsibilities:

  • Ensure compliance with IVDR 2017/746 and ISO 13485 regulations.
  • Develop and maintain Design History Files (DHF) and oversee design control processes.
  • Assist in the development and maintenance of records and procedures within the quality management system.
  • Participate in regulatory audits and certification inspections.
  • Evaluate and interpret regulatory requirements and industry standards.
  • Conduct comprehensive compliance assessments.

Qualifications:

  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • Proven experience in quality engineering within a regulated industry.
  • Strong understanding of regulatory compliance and quality management systems.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal abilities.


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