Critical to the process is a solid implementation. We will be there to assist our clients through this process until completion.
Nicole Baldridge, President of Baldridge Consulting, is also our lead consultant. Nicole has worked within the regulatory and quality environment for over 20 years. She has background ranging from automotive and aerospace to medical devices and API's. She is certified Lead Auditor for multiple regulations 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.
Michael has an extensive Quality background, ranging from Medical Device manufacturing to Automotive. Michael holds a bachelors degree is Organizational Management. 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!
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.
Call Us at +1 (517) 242-8199
or Email us at: Customer.firstname.lastname@example.org
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.
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.
Julia has a full complement of medical device experience that she brings to the Baldridge Consulting team. Julia has worked within the regulatory and quality environment for 10 years. Her background includes implementation and maintenance of quality systems as well as international regulatory submissions. She is a certified Lead Auditor under ISO 9000 with emphasis in ISO 13485. Julia also has vast experience in managing a fleet of sales and marketing staff for both international and domestic distribution.
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, 2017/745, CMDR Part 1, SAE AS9100D, IATF 16949 or FDA cGMP for devices or API 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, 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. Contact us today and we can build a custom package that will meet your regulatory needs.
A good company knows when they need us; a great one won't need us again!