I have worked in regulatory and quality teams for surgical eye implants, virtual reality based devices and wearables for remote patient monitoring, along with providing thought leadership on artificial intelligence regulation.
How did I end up working with medical devices? Reflecting on my career, it's been diverse. Three years ago, I was working on protein structure in research labs. I never thought I'd be in the world of quality later on!
A good QMS will control nonconformities by acting as a defense line, catching discrepancies and abnormalities in products before they ever reach the customer.
Manufacturers thrive in a competitive market by prioritizing customer needs: price, quality, and delivery. However, long-term success hinges on quality, which ensures products perform as expected from manufacturing through to post-sale. While price is influenced by costs and market dynamics, and delivery by productivity, quality is key to building trust and customer loyalty.
The quality department is well positioned to address energy efficiency within an organization. Efficient processes are a cornerstone of quality management.
A paper released by the U.S. Energy Information Administration (EIA)
addresses the importance of renewable energy in mitigating climate change and the challenges posed by the global energy crisis. It emphasizes the need to improve energy efficiency in response to increased energy consumption worldwide.
Quality starts with requirements. Conformance to requirements is important, but not enough. The quality of the requirements is equally critical. An effective quality management system ensures that requirements are not only present and up to date, but also adequate for creating quality.
Manufacturing compliance goes beyond ticking boxes; it's about trust and excellence. Small manufacturers can navigate complex regulations by understanding compliance history, using technology, and implementing effective strategies for success.
Boeing needs to improve its manufacturing approach to prioritize transparency and continual improvement, which can also help other organizations improve their quality and bottom line.
Outsourcing began due to a lack of skills and the desire to handle tasks internally. To bring manufacturing back, we need to ensure top quality and manufacturing in America. Find out what we need to focus on.
A quality management system program ensures that products and services meet predefined standards, customer expectations, and company-wide benchmarks. One key principle is "first time right," addressing errors immediately at every step.
If you are a quality management professional or part of an organization in the aerospace and defense industry, seeking AS9100 certification can be critical to your success.
AS9100, the global quality management standard for aviation, space, and defense, reflects this commitment to excellence. Obtaining AS9100 certification is vital for success in this sector. This guide assists organizations in navigating the certification process, ensuring the implementation of top-quality practices across their systems.
SHE requirements are standards and practices to ensure the safety and health of employees, clients, and the public, and to protect the environment. They arise from legal regulations, industry standards, and best practices to minimize occupational hazards and environmental impacts.