Tuesday, May 15, 2018, at Ali Baba Restaurant, 17513 Chatsworth Street, Granada Hills, CA 91344, 5:30pm
Abstract: The management review cadence evaluates the efficacy of the quality system against key performance indicatorsor metrics established by leadership. Timeliness of activities such as customer feedback, training, and internalaudits are reviewed robustly; however, there is still an opportunity to actively address the needs of the customer.Understanding the needs of the customer allows the company to deploy resources and solutions to reportedcomplications of breast implants and cardiac ablation procedures. The tools that allow for this understanding arebased upon the Law of the Market and the Law of Focus. Information from different channels can be aggregatedvia quality management tools such as affinity diagrams, interrelationship digraphs, and impact effort matrices.Links between various ailments and product design have been found, using these tools. Information from availablechannels of customer communication can be leveraged to further reduce reporting of signals due to productimprovement.
By attending this clinic presentation, you will:
- Understand the current state of medical device management review body of knowledge.
- Apply certain quality management tools to further understand product issues and impactful solutions.
Speaker Bio: Monica Daneshrad is a Senior Quality Engineer currently employed in the medical device division at Johnson &Johnson in Irvine. She has accrued eleven years of experience in the quality systems field having worked atcompanies such as Siemens and Allergan. She has implemented and led process improvement initiatives inDocument Control and Internal Standards. She currently supports management reviews for 7 Johnson & Johnsonbrands.
Monica holds a Bachelor’s of Science in Biology/Spanish with a minor in English from Loyola MarymountUniversity. She has the following ASQ Certifications: Yellow Belt, Green Belt, Black Belt, and Manager ofQuality/Organizational Excellence. She holds a Project Management Certificate from UC Berkeley and is anMSQA Candidate at California State University-Dominguez Hills.