Director, Design Quality Assurance - Pleasanton, CA

Education: Bachelor of Science in Engineering or Life Science discipline.

Minimum 15 years experience in Quality Engineering/Assurance in the medical device industry including 5 years in a managerial role.

Work location: Pleasanton, CA.

Travel: Ability to travel 10 - 15% Domestic and International to suppliers and contract manufacturing sites.

Full-time employment.

Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971, 62366; IEC 60601-1, IEC 62304 and related regulations.

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes:

A competitive base salary of $200,000 - $230,000 and variable incentive plan

Stock options – ownership and a stake in growing a mission-driven company

Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only