US-NJ-Mahwah: QA Compliance Auditor

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.

To apply for this position, please visit this Website.

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