Director of Quality & Regulatory
Laura has over 30 years' experience working in Quality Assurance and Regulatory Affairs for the medical device industry. During her career, she has gained experience in all aspects of the industry from product development to customer delivery. This would include management of projects, priorities, personnel and budgets, 510(k)/PMA/Technical File development, product design review, product qualification, manufacturing process development and validation, inspection systems design and development, vendor audits and vendor qualification, inventory control of received materials, in-process product and finished goods, microbiologic and chemical controls, environmental and cleanroom requirements, and sterilization of finished product. She is expert in GMP/ISO compliance, auditing, quality systems development, product complaint evaluation/MDR reporting, FDA-483 resolution, GMP training, and standard operating policy, procedure & protocol technical writing. Laura provides strategic planning and systems development geared toward improving overall company efficiency, product quality, customer satisfaction, market reputation, and ultimately a corporation's profitability.
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