Description:
Ajilon Consulting has been a premier provider 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.


Candidate must be Green card holder or Citizen

. 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.
. Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of clients Orthopaedics Business Process Excellence initiative.

Experience:
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.