Design Quality Assurance Specialist
3 weeks ago
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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