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Director of Quality Assurance, Medical Device

Location: San Francisco, California, United States
Reference ID:

Our exciting medtech partner is building the future of medical robotics with their next-generation robotic platform that targets early diagnosis and treatment of patients across multiple indications.  They are looking for talented medtech professionals with the vision and the desire to make an impact in the industry with disruptive and exciting technology.  The Director of Quality Assurance or Senior Manager of QA will lead the day-to-day Quality functions for RA/QA through all stages of product development including design quality, ISO 13485 & 14971, hiring and training a quality team, process validation, and SOPs for the QMS including overall implementation.

The Right Talent:

BS Degree in Engineering or relevant field

10+ Years of Quality Experience in the Medtech industry

3+ Years of Leadership experience with direct reports

Preference for someone with experience in a start-up environment with execution on NPI and Product Launch 

Experience implementing a new QMS or QMS remediation or integration experience preferred

Expertise in ISO 13485 & 14971, Risk Assessment, Process Validation, SPC, and Design Quality

Experience in sterile processes preferred

Strong mentor with a hands-on approach 

 

 

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