PROFILE Quality Assurance and Regulatory Affairs professional with experience in the medical device manufacturing industry. Developing and introducing FDA Class I & II digital medical x-ray equipment, laser radiography scanners, pharmaceutical ultra and micro filtration and separation filters, and blood filters. Manage and develop Quality functions (quality planning, new product development, design controls, quality engineering, quality metrics, CAPA, and validation activities). * cGMP Compliance - Design Controls - Six Sigma Black Belt - FDA 510K Submissions - Host Regulatory Audits - Problem Solving

Highlights:

• Email
• Engineering
• Medical
• Medical Devices
• Pharmaceutical
• Problem Solving
• Quality
• Quality Assurance
• Statistical Analysis
• Test