Design Quality Engineer
2 weeks ago
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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