Quality Assurance Manager

Quality Assurance Manager - Odyssey Medical, Inc.

• Quality Management Representative

•  Assure compliance to regulatory requirements through timely regulatory planning, submissions, reporting, and compliance activities.

• Assure conformance and development of the quality management system to meet all applicable standards. 

• Direct responsibility for Quality System policies, planning and objectives.

•  Support the development and implementation of emerging technologies through development of quality management systems and by addressing regulatory requirements.

• Provide timely support to the development function through quality planning, approvals, new product introductions, and production support.

• Provide leadership in the development and implementation of company process improvements/cost reduction programs.

• Provide oversight of development/ management of company supplier quality system.

Quality Assurance Manager - Odyssey Medical, Inc.

• Thorough understanding of FDA Quality System Regulation and ISO 13485, 2003

• Must have medical device management experience

• Must have experience with continual improvement, 5S, Six Sigma, Lean Manufacturing and Gauge R&R

• Experience with domestic and international medical device regulations

• Bachelor’s degree required

• Six Sigma Green Belt required