Description:
Ajilon Consulting has been a premier provide of information technology (IT) business solutions since 1969. With over 50 offices in North America and 10,000 employees worldwide, Ajilon Consulting is a company full of opportunities and exciting new challenges.

Ajilon Consulting is seeking multiple QA Compliance Auditors to support our medical technology client.

Since these are full time positions with our client, you must be either a US Citizen or Green Card holder.

Your responsibilities will include:
. Perform 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.
. Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of the client's Business Process Excellence initiative.

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


Since these are full time positions with our client, you must be either a US citizen or Green Card holder.