Director of Quality Assurance and Regulatory Affairs

The Director of Quality Assurance and Regulatory Affairs will develop quality plans and controls around new product development, assist with continuous improvement, and insure product safety requirements are met.  Excellent benefits and relocation package.  Must have BS or advanced degree (preferred) in a scientific or engineering field with 7 to 10 years experience; 8 plus years QA/RA experience, in medical devices (ortho, specifically spine, preferred), with greater than 3 yrs experience as manager of QA/RA activities.  Demonstrated knowledge of the European Union Medical Device Directive governed quality systems and approval processes for medical devices.  Possess a strong working knowledge of FDA’s Quality System Regulation (QSR) and practical application through design control, SOP’s, verification, and validation testing, with experience in creating quality systems.  Experience with QA audits, interfacing with, approving, and auditing suppliers and interfacing with FDA and Notified Bodies during audits.  Proven track record of successful regulatory audits.  Up to 20% travel required.  Salary plus bonus. For SCM, Six Sigma, Lean Management, Quality and Engineering or Medical Device / Biotech opportunities; please visit our website at http://www.fpcgboro.com.