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
