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Team Member Spotlight: Ella Wheeler

Quality culture. Continuous improvement. Lean and Six Sigma.

At QA Consulting, our team members strive to be trusted partners for our clients and from time to time, we will shine the spotlight on a QA Consulting team member so you can get to know them. Today, we’d like you to meet Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant.

Here are her quick tips for tackling continuous improvement in your quality assurance programs

Quality is the foundation of a successful medical device product launch.

Continuously improving your quality system throughout a project reduces the risks associated with bringing your product to market and saves you from a significant hit to your bottom line due to the unexpected costs of poor quality.

When developing and improving your quality systems remember to:

  1. Listen and take time to define the correct problem
  2. Make sure you have a cross-functional team to help you solve your problem areas
  3. Assess and use the right tool for your problem

Get to Know the Experts—Four Questions with Ella

1. What is your primary area of medical device expertise?

While I consider myself a perpetual learner, my knowledge stretches from quality systems, audits, regulatory compliance, to continuous improvement. And that last skill, in my opinion, connects all quality and regulatory and operational aspects within a company. Something new that I’m bringing to the team is Lean and Six Sigma skills.

What do I mean by that?

Lean and Six Sigma methodologies are part of the continuous improvement toolkit that enable change and cultural evolution. So if you think about it, lean focuses on eliminating waste. And Six Sigma, on the other hand, targets variation reduction. Together, they are great tools for improving any process. And if you improve the process, you can see that in the bottom line of any business. For example, look at Motorola, right, it’s an old example, but applicable over decades. After using the Six Sigma principles to curb their production defects, Motorola reportedly realized $16 billion in savings in 12 years. Our clients see the potential there.

2. How do you partner with the medical device industry?

Every client is different. Every business is different. And every business model is different. QA Consulting brings an a la carte menu of solutions. We can support businesses from concept to industrialization, everything from quality engineering during your design phase to post-market surveillance—it’s pretty much soup to nuts.

We work side-by-side with medical device teams on process improvements and cultural change. Or we can simply deliver training for lean methodologies. We offer customized services, like an audit, design documentation or complaint handling. Really, it’s up to the client and based on their needs.

Keep in mind that in order for organizations to find support for all these areas, it takes time. We help reduce that burden.

Regardless of the service, I request a few things from new clients: not being afraid to ask for help, remaining open to suggestions, and allowing everyone to think outside the box for the best solutions.

3. What should all medical device companies remember to focus on?

Quality culture.

Culture is a big part of making the improvements in the company and for sustainable growth.

  • Culture, by definition, means all your employees and your team works together and is connected to the business mantra. There’s a saying somewhere on quality people’s walls that says: quality is doing something right when nobody’s looking. In order to have a sustainable quality culture, you want to make sure quality is on everybody’s action list.

This is possible when people understand and connect with the meaning of following procedures, not just because they’re there, but because it brings value to the customers. When teams work together, and are in agreement with a dedicated process, it translates into a culture where everyone wants to do the right thing and move in the same direction together as a team. The company only benefits from this.

4. What’s one thing we’d be surprised to know about you?

One thing people don’t associate with cooking is zen and relaxation. However, when I’m not taking a walk in the woods with the dogs, that is where I find my quiet corner and where my creative moments come alive.

There is something about baking a delicious puff pastry or making a pot of Romanian Borscht on a cold fall evening—there is just something very relaxing about it.

Connect with Ella on LinkedIn

What Ella is Reading

Transforming Quality Organizations: A Practical Guide by Matthew P. Wictome and Ian Wells

  • A “Cause and Effect” map of relationship between Quality and Leadership, meant to challenge the status-quo. The book is ‘the practical guide’ to creating a perfect symbiosis between Quality, People, Technology and Customer needs, in other words, the guide to a successful Quality Transformation. Don’t put down this book until you reach the last page!

Measure What Matters: How Google, Bono and the Gates Foundation Rock the World With Okrs by John Doerr

  • Although OKR (Objectives and Key results) is only one methodology out of many used to set and implement key strategic milestones, you don’t have to be a disciple of the method to see the value in the content of this book. It provides a plethora of case studies that are universally applicable to anyone determined to improve their organization and to become a better leader.

Creating a Culture of Excellence by KPMG International’s Healthcare Practice

  • A report about sustainable change in the healthcare industry. The KPMG team demonstrates through multiple global case studies and practical expertise, how complex, yet collaborative continuous improvements, supported by data, buy-in and empowerment help create an efficient, quality driven organization. “And the ‘cost vs quality’ argument becomes redundant”.

Also, don’t miss what’s new on our blog:

Lean into quality with medical device systems everyone can trust.
Contact us today to set up a discovery call!