Sr. Design Quality Assurance Manager

Job Qualifications:

· Bachelor's degree in Biomedical, Mechanical, Software, or Chemical Engineering, or related field.

· Master’s degree in relevant field of study, preferred

· Seven or more year’s direct management experience in the medical device quality management function

· Hardware and Software QA design experience

· Strong knowledge of global regulations, demonstrated track record of effective management of regulatory agencies, and working knowledge of global product approval processes

· Demonstrated experience in compliance to QSR, GMP and ISO regulations

· Demonstrated desire and ability to lead continuous improvement programs and design/process reliability improvement initiatives

· Project management experience and demonstrated skills

· Internal and external audit experience, preferred

· Excellent track record in effective communication, planning and cross-functional collaboration

· Strong planning, partnering and organizational skills

· Strong data management and computer skills

· Knowledge of U.S., European and International regulations and standards covering medical devices.

· Experience with FDA and ISO audits, practical experience with ISO 13485, QSR, ISO9001.

· Excellent verbal and written English skills