NJK & Associates, Inc.

Helping you jump your highest regulatory hurdles

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Our Mission:

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.

Staffing vs Outsourcing

If your organization is contemplating hiring a full-time QA/RA professional, you face a dilemma: (1) hire a more seasoned QA/RA professional who will be underutilized for much of his/her time, or (2) hire a more junior QA/RA professional that is not experienced in creating and operating a quality system and doing regulatory submissions. Of course  you could contemplate hiring a seasoned QA professional AND a seasoned RA professional but then the costs go sky high and they are both underutilized.

Hiring overqualified staff is expensive and more often than not leads to them leaving after a short time. Seasoned professionals like to be challenged, and generally dislike not being used to their potential.

On the other hand, hiring junior personnel saves money. But their lack of experience can lead to implementation of overly complex systems and ultimately to quality and regulatory issues that cost time and money to fix, all the while damaging your company's good name.

Another challenge is that the hiring manager is often inexperienced in QA/RA and so does not know how to choose the best person at any level of accomplishment.

These are just some of the reasons why it often makes sense for small and mid-sized companies to consider engaging the services of professional QA/RA consultants. A good consultancy can act as your outsourced QA/RA department, and can help with the transition to full time employees as the need arises.

 

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.

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