We strive to provide our clients the expertise they need in a manner that we would expect it to be provided to us.
Welcome to NJK & Associates
NJK & Associates was founded in 2006 when Natalie Kennel, RAC, ASQ CQE & CQMgr recognized an unmet need in the medical device community: QA/RA help from industry experts willing to get their hands dirty.
Her years of experience in industry as well as her lifelong pursuit of learning led to the realization that the way much of industry was approaching QA/RA was by growing systems with ever increasing complexity. She recognized that unnecessary complexity leads to employees finding ways to work-around the systems and to lacks of conformance both to the systems and the regulations. Her better way was the creation of our first, from-scratch quality system. Over the years this system has evolved, but remains "as simple as possible, but no simpler". It has proven to be effective with clients ranging from 3 person operations to multinational giants.
The company quickly grew by the addition of a small group of employees and a larger group of world-class associates already successful in their own endeavors and accustomed to working with the NJK team. The later group includes regulatory and labor law attorneys, human factors and usability experts, software engineers, contract design houses, contract manufacturers, and test labs. This group of individuals and companies have demonstrated time and again that the right people with the right skills and working in coordination can accomplish what our clients desire.
Our Name, Our Logo, Our Passion
NJK & Associates, Inc. was founded by Natalie J. Kennel, RAC, ASQ CQE & CQMgr who serves as its president. Prior to her consulting career she worked for companies designing and manufacturing IVDs, surgical devices, and infusion pumps. Natalie has held a variety of roles in quality, regulatory, development, and manufacturing in both large and small companies. Natalie is expert in the development of new quality systems, software validation, and companies with regulatory agency "issues".
Every so often in life one comes across truly exceptional people and businesses. When that happens to us we strive to form lasting relationships. When those individuals and companies happen to have talents that can benefit our clients we play matchmaker in order to collectively provide services that delight our clients.
Our logo suggests that we are interested in horses, and jumping in particular. That would certainly describe one of our passions when not working. It also describes what we think differentiates us from others in the field, namely we take an active role in helping our clients to succeed. It is not within our personalities to merely suggest solutions, we make them happen by getting our fingers dirty alongside your employees.