US-NJ-Mahwah: QA Compliance Auditor
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99679014_QA_Compliance_Auditor.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 05-Mar-2009



QA Compliance Auditor

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Performs internal quality assurance audits to 21CFR 820, ISO
9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to
ensure corporate and regulatory compliance. • Perform external quality
assurance audits on new and existing suppliers to ensure compliance to
corporate requirements. • Ensure effective closure, by working with
auditees to ensure comprehension, development, and execution of
corrective/preventive action with regards to any nonconformities cited
during audits. Create formal audit reports and assign associated
corrective actions. • Develop/modify audit checklists as regulatory
requirements change. • Present internal audits findings quarterly at
management review meetings. • Develop and conduct effective training
programs on related QA topics. • Conduct and support benchmarking
activities. • Identify areas of opportunity and support continual
improvement of the Quality Management System. • Identify, develop, and
report QMS metrics.

QUALIFICATIONS:

• 3-8 years auditing experience in medical device or other regulated
industry. • Project Management experience. • PC Proficiency. • Strong
organizational and written/verbal communication skills. • Self-
motivated with the ability to effectively work with others in various
coordinate disciplines, on multi-national teams, and to prioritize
tasks in a deadline-driven environment.

EDUCATION:

• Bachelor's Degree required. • Internal or lead auditor certification
(CQA/CQE) required.



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

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