Our client is an established and thriving medical device company that is growing rapidly. In this multi-faceted leadership role, you will work cross-functionally on quality initiatives designed to incorporate best practices in safety systems, risk analysis, validation and verification, combination product regulations, and complex medical device design.
Knowledge and experience with:
· Design controls for medical devices (ISO 13485 and FDA 21 CFR 820.30)
· Quality system regulations (FDA parts 211, 820; and ISO 13485; Biologics regulations)
· Medical device risk analysis (ISO 14971:2007, EN ISO 14971:2012, FMEA, FTA analysis)
· Usability/Human Factors engineering (IEC 62366:2007, ANSI AAMI HE-75:2009, FDA’s Human Factors Guidance)
· Electrical Safety Standards (IEC 60601-1; collateral standards IEC 60601-1-X series; particularly standards IEC 60601-2-XX series).
· Design Validation and Verification, Process Validation
Inquiries and resumes to: Kathy Provost at firstname.lastname@example.org OR 978/952-6425
For more information, please visit http://www.agilesearchinc.com/