A company is looking for a Head of Design Quality.
Key Responsibilities
Lead Quality representation in Design and Development Projects
Manage Risk Management file creation and maintenance for products
Provide Quality Assurance support for assay and software verification and validation activities
Required Qualifications
Bachelor's degree in Life Sciences or a related field preferred
15+ years of experience in a Quality Management role in the Medical Device industry
Over 4 years of IVD experience with FDA approved class III IVD products
Single site PMA experience required
Expertise in interpreting 21CFR820 and relevant ISO standards
Director Quality • Carrollton, Texas, United States