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Responsible for developing and improving Quality systems in compliance with requirements through auditing, gap assessment, remediation, and management of Corrective/Preventive actions. Key responsibilities include contributing to Quality System development, improving Quality systems, conducting audits, and supporting regulatory inspections. Requires a Bachelor's Degree and experience in the medical/diagnostic device industry with knowledge of quality standards and regulations.

Seeking expert personnel with backgrounds in Regulatory Affairs, Quality Assurance, Clinical Trials, Auditing, Medical Writing, and Laboratory services to accelerate the success of medical device, IVD, and combination product companies through industry-leading regulatory and quality consulting solutions.