Design Quality Engineer

2 weeks ago


Middletown, United States Intellectt Inc Full time

Job Title: Design Quality Engineer

Location: Middletown, VA

Duration: 6+ Months


Key Responsibilities:

  • Demonstrate knowledge in the application and implementation of IVDR 2017/746 and ISO 13485.
  • Create 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 to ensure regulatory compliance.
  • Participate in regulatory audits and certification inspections, ensuring operational compliance with established procedures.
  • Evaluate and interpret regulatory requirements and industry standards relevant to operations.
  • Conduct comprehensive compliance assessments to identify gaps and areas for improvement.

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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