[Outsource:55934] US-MD-Gaithersburg: Director, Software Quality

US-MD-Gaithersburg: Director, Software Quality
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99666833_Director__Software_Quality.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 29-Sep-2011

Director, Software Quality

Responsibilities • Development and maintenance of software Quality
Assurance procedures • Product and non-product software Quality
Assurance including software development lifecycle and validation. •
Support new product submissions for products containing software. •
Review and/or perform software validations including:preparing
protocols as well as reviewing and approving protocols from other
authors • Assist in design, development and maintenance of a Quality
System compliant with cGMPs and ISO and other International
regulations.

Position Requirements • BS or MS degree in technical/scientific/
engineering discipline • Minimum of 8 years of experience in medical
devices, in vitro diagnostics, pharmaceuticals or a related industry.
• Experience working with the FDA and/or ISO auditors required. •
Experience with new product submissions for products containing
software required. • ASQ certification (CSQE, CQE, CRE, CQA) is
preferred. • Excellent working knowledge and experience of FDA's
Quality System requirements (QSR),ISO 9001 and ISO13485:2003 standard.
• QA experience in software required. • Ability to coordinate multiple
projects.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

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