Must have a technical background, be familiar with applicable US and foreign regulations, standards, corporate and divisional standards. Specifically, the individual must have a working knowledge of Quality Systems Regulations (QSR) and International Standards (ISO13485). Additionally, the individual must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, and understand the principals of quality management. Bachelor degree (in Engineering preferred) or equivalent experience and sufficient exposure to pharmaceutical or medical device related industries required along with 4+ years relevant experience as Internal Auditor, Quality Engineer and/or Manufacturing Engineer in an R & D and /or manufacturing environment in pharmaceutical or medical device related industries. Position requires significant product and systems related knowledge. Must have excellent oral and written communication skills.