US-FL-: Quality Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
* 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 FDA’s 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:
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI