Quality Management Director

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