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Sr. Design Quality Assurance Manager

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Quality
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1700052H Requisition #
Thanks for your interest in the Sr. Design Quality Assurance Manager position. Unfortunately this position has been closed but you can search our 1,337 open jobs by clicking here.

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

· Solid knowledge and track record in the application of Design Controls, Risk Management and Statistics towards supporting new product development and sustenance of market released medical devices

· 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

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