FierceBiotech and FiercePharma Jobs
Quality Specialist - Autonomic Technologies
Jan 08
Location: Redwood City, , California Categories: All Categories
Website:
Position Description
Autonomic Technologies is a small, early stage start-up company developing implantable neuromodulation therapies. Founded in late 2007 with initial funding from Kleiner Perkins Caufield & Byers, ATI is working in collaboration with the Cleveland Clinic to develop this technology for headache patients.
In this exciting opportunity you will be responsible for the implementation of ATI’s ISO 13485:2003 Quality Management System and 21 CFR Part 820 FDA Quality System Regulations with a focus on product development.
The qualified candidate shall have a minimum of a BS degree in engineering and a minimum of 3+ years Medical Device QA experience.
The ideal candidate will also have the following experience/attributes:
• Thorough knowledge in the documentation compliance requirements for FDA and ISO 13485:2003
• Excellent oral/written communication skills
• Strong organization/planning skills
• Working knowledge of ISO 14971 Risk Management
• Miniature parts inspection and/or design experience a plus
• Vision for how quality systems improve product development and the leadership ability to work with cross functional teams in a small start up to implement those systems.
ATI is located in Redwood City east of the 101, with a wonderful view of the bay and water wildlife. We offer a competitive benefits, salary and stock participation package. We are confident you will enjoy working with our team of intelligent and innovative professionals.
