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Nicole Baldridge, President & CEO, is also our lead consultant. Nicole has worked within the regulatory and quality environment for over 20 years. She has background ranging from AS9100 to ISO 13485 and everything in between. She is certified Lead Auditor for multiple regulations through BSI America and spent 5 years as a Lead Assessor, mentor and trainer with BSI. She has implemented and run quality systems in both the automotive sector as well as the medical device field.
Critical to the process is a solid implementation. We will be there to assist our clients through this process until completion.
Together, key performance measures are developed. On a scheduled basis they will be reviewed for effectiveness and success toward the goals set in the planning phase.
With our clients as our team members, we will identify the specific needs of the system and put together a detailed action plan for success.
President & CEO
Because no two clients will have the same path, Baldridge Consulting, LLC uses a collection of different assessment tools to determine the unique needs of each of its clients.
Michael has an extensive Quality background, ranging from Medical Device manufacturing to Automotive. He has increased productivity levels at a previous plant and streamlined our supply chain at another by implementing additional steps up front to ensure the company remained profitable on new product launches. He has had the privilege of launching an entire plant and he is fully aware of the types of obstacles that ensue this, and the rewarding feeling of its success. He has driven Lean tools throughout an organization along with working across the corporation for Lean tool Standardization. He has mentored and trained personnel on A3 thinking, DMAIC, & the 8D process on multiple occasions. He is a huge proponent of Lean Implementation, and firmly believe it can be utilized in any organization!
We offer consulting, training, auditing, and many other services both in person and online for organizations of any size interested in quality and regulatory. Whether you need to implement a management system to comply with ISO 9001, ISO 13485 standard, MDSAP, 93/42/EEC, CMDR Part 1, AS9100C, IATF 16949 or FDA cGMP we are ready to help. Not only do we have the resources to facilitate the implementation of quality management systems, We also have the expertise to help you with training, Internal audit, FMEA training, ISO 14971 training, CAPA, Supplier Audits, and so much more. We are unlike most quality management consultation businesses in that we teach you how to do what needs to be done in the areas you need it. This method allows you, the client, to become the expert so that future implementations or issues will not require external assistance. Also we pride ourselves as being able to provide consultation and implementation resources for all of your needs, at a cost that will not break your budget. Our focus is on value-added processes and team training.
We also offer an "on demand" regulatory contract for those who might not be ready for that full time Director of Regulatory staff position.
A good company knows when they need us; a great one probably won't require our assistance again!