SQAFYI - Software QA Resource - FYI

US-FL-: Quality Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 04-Apr-2013

Quality Engineer

* Ability to serves as a Quality resource/facilitator for audit programs including internal audits (routine and directed), external audits (e.g. FDA, ISO, etc.), supplier audit/qualification, and process validation. * Hands-on process validation experience * Experience leading/mentoring other validation professionals * Ability to support Quality Management System (e.g., facilitate change orders, CAPAs, Document control, Design Control System).

* At least 2 to 5 years of experience working as a Quality Engineer; preferably in a CBER, CDER or CDRH regulated facility, required. * Must have experience with the application of the FDAs Quality Systems Regulations (21 CFR Part 820 [especially design control requirements] and 21 CFR Part 11) and ISO quality regulations (13485 and ISO 14971). * Experience as Lead Auditor in medical device/pharmaceutical auditing practice, required. * Hands on experience with supplier auditing, qualification, and process validation, required. * Excellent oral, written and interpersonal communication skills with all internal and external customers are requiredSubject:

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

US-FL-: Quality Engineer