I’m looking for a Quality Manager to assist in the development, continuous improvement and maintenance of the Company’s Quality Management System to meet the requirements of the FDA's QSR, ISO 9001:2000, ISO 13485:2003 and other standards as required.

This is a perfect opportunity for a strong QA Engineer or a Quality Manager that is looking for a change. The candidate will:

• Work with QA/RA Director in managing the process metrics and trends leading towards Corrective Action and Continuous Improvement efforts.
• Perform Quality Engineering activities for TPA projects such as creating quality plans, providing input to decisions and deliverables with QSR and ISO requirements, reviewing and/or approving DHF deliverables and working to assure Customer Satisfaction.
• Assist in the development and implementation of Software Quality Plans/Protocols.
• Assist in the Internal Audit process for the Business Unit. Conduct audits, review and approve root cause and corrective actions and evaluate the effectiveness of corrective actions.
• Conduct Software Quality Assurance (SQA) audits. Provides monthly status reports of ongoing SQA audit activities and elevates non-compliance issues to higher level management.

An ASQ Certification preferred - CQA, CQE, CQM

Good working knowledge of the FDA's QSR, ISO 13485:2003 and ISO 9001:2000

Excellent communication both written and verbal

Proven track record as a dynamic team leader

Please contact for more details or forward as appropriate.

Kathy Kallapos

Larson, Katz & Young, Inc.

Healthcare Technology Recruiters

P.O. Box 44

Aldie, VA 20105

703-327-1151 Ext. 12

kathy@lkyi.com