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QA/RA: Going from policeman to partner

During this episode, Guenter Weisshaar, answered the frequently asked question, “What steps can QA/RA professionals take to be seen as solution providers and business enablers, instead of policemen?”

Guenter joined the QA/RA function over 30 years ago when the role wasn’t well defined. Over the years, he has seen the perception change and he has contributed to that change which is why we asked him to share his experience and key learnings to help other QA/RA professionals become more effective in their roles.

Starting out in quality control, he has risen in his career to where he is now; Senior Vice President of Quality and Regulatory Affairs at Tecan. Tecan manufactures and distributes laboratory automation components and systems, and Guenter has been part of the organization for 18 years.

Prior to Tecan, he worked at Jomed AG, Schneider Europe and Schottli AG. He has experience in implementation and certification of quality management systems (ISO 9001-2015, ISO 13485-2016, QSR 21 CFR 820, IVDR) in multiple Medtech and IVD companies. He’s also a certified enterprise risk manager according to ISO 31000 and he’s been a project leader for many global projects in the area of innovation management, quality management and enterprise risk management.

Embarking on a Career in QA/RA

Guenter was educated in the military as an aircraft engineer. His career in QA/RA began in a quality control department at ASEA Brown Boveri which is currently known as ABB. From there he worked at several other companies.

His introduction to the medical device business was when he moved to a mold maker company which made molds for medical device parts, syringes, and a lot of other devices which are used in the laboratories.

He was there for more than 10 years, after which, he moved to Schneide Europe where he came into contact with Class 2 and Class 3 medical devices.

He believes it’s important for anyone in QA/RA to start at the bottom as they work their way up to a leadership position so that they’re aware of the challenges QA/RA professionals experience and hence, will be better equipped to solve those issues.

The Role of a Quality or Regulatory Professional

Obviously, QA/RA professionals need a huge skillset and should be well versed with industry regulations. Guenter advocates for QA/RA professionals to work towards being more than experts in QA/RA and invest in becoming business enablers, networkers and promoters.

He believes QA/RA should be all-rounded stating that, “A great QA/RA person needs to have the skills similar to a scientist because you have to understand the application of your instrument and how your product is used.

You have to have skills like a lawyer because you have to understand the regulations and translate them into a language that your counterparts understand.

You have to be like a politician; doing audits, be very careful on what you talk about so you don’t say too much and it cannot be used against you.

You have to be like a technician because you have to know the functions of the instruments.”

Being able to move from technical skills to social skills and emotional intelligence is the key to being a successful QA/RA professional.

How to be a Business Enabler as a QA/RA professional

Sales people tend to avoid letting QA/RA professionals and customers meet because they don’t speak the same language which is detrimental to the business. “You need to get to the point where you can communicate the advantages of a compliant management system and I am purposely not talking about quality system.

QA/RA professionals should be able to describe the competitive advantage and show clients the differentiator”.

At Tecan, the QA/RA department has built the trust of the sales team because QA/RA helped bring in projects from large diagnostic companies. Today, Tecan’s QA/RA team is doing just as many presentations as the sales team, if not more.

By being a business enabler, you have to earn the trust of both internal and external stakeholders by contributing positively towards their interests.

Building Relationships as a QA/RA professional

On a personal level, learn more about your colleagues. Go beyond knowing what their job title is and get to know who they are as a person. Connect with them.

On a professional level, don’t be the ‘either yes or no’ guy. Provide solutions. When you face a challenge in your organization in regards to quality/regulatory, don’t be rigid and dictate one unfavorable path. Consult your colleagues and come up with at least 3 solutions. “Go back to your stakeholder and say, ‘Look, I have been thinking about your problem and I can give you three options you could go for. I have checked it from a risk point of view and a compliance point of view.’”

They get very pleased that you’ve provided them with options and when they choose one, help them to execute it which will help you be perceived as solution-oriented, supportive and a business partner.

Negative Tendencies of the QA/RA Field

    1. QA/RA departments usually don’t report to top management. It’s important that they do so, so that their interests, philosophy and culture gets established in the company.
    2. Old fashioned QA/RA people tend to have a victim mentality. People won’t believe you or trust you as a QA/RA professional with this mentality. Approach challenges and stakeholders with a zeal that wins them over and buys into your solutions.

Skills That QA/RA people Will Need in the Future

Knowing who QA/RA professionals will have to deal with in the future indicates what skills they’ll need. They will have to deal with all the management levels in the company, starting from operations, to R&D, top management and customers and suppliers.

    • Communication is a key skill to have to be able to interact effectively with each department and QA/RA professionals should do it in a way that the group they’re talking to understands them.
    • Presentation skills should be mandatory, even now.
    • Networking.
    • Relationship building – Building relationships with your customers and helping them solve their challenges will improve the reputation of your department.
    • Self-promotion – A lot of QA/RA people do a lot of good work but they don’t talk about it so people aren’t aware of their contribution and their role in the company can be undervalued because of this. Sell what you and your team are doing because what you are doing is important to the patients, to the customers, and to the business.

Tips on How Introverted QA/RA Professionals can Sell Themselves

Proving your value to the company is one way of self-promotion that anyone can practice regardless of their personality type. If the business realizes that you are a business partner and you are solution-oriented, then that is promotion by itself.

During presentations, share your success stories. Success stories motivate your team and it garners trust with your stakeholders.

Sharing what you do may seem cringeworthy to introverts but look at it as a way of educating people about the function of QA/RA. For example, if salespeople in your company become aware that one of your objectives is to help sell medical devices then they will collaborate with you but if they’re ignorant about your department’s objective, then they won’t involve you and you’ll come short.

How to Sell QA/RA to Stakeholders

To convince management and other stakeholders about the importance of certain regulations and protocols, you have to speak their language by linking what needs to be done to revenue or whatever is important to them. Show them how being up to date with QA/RA gives them a competitive edge and can increase their market share. List the consequence of how not complying will cost them in the long run.

Identifying Whether a Company has a QA/RA Culture During Interviews

“The first thing I always asked when I was approached by other companies was who is the QA/RA function reporting to? If it was reporting to the head of operations then I declined the job offer.” Knowing where the QA/RA department is in the organization chart will show you whether a company has a QA/RA culture.

Talking to people like managers at the company you’re interviewing for can inform you about their culture and prepare you to ask the right questions during the interview. Questions you could ask to gauge the QA/RA culture of a company are:

    • What is your quality perception in the company?
    • What is the culture of your company?
    • Is QA/RA a topic in your leadership meetings? If QA/RA is not a topic in the leadership meetings or in their management board meetings, then it’s not important to the company.
    • Do you have a lot of quality topics to be addressed?
    • Why do you want to hire me? Is there a specific need you want to be addressed?

Changing the Negative Perception of QA/RA to a Positive One at Your Workplace

QA/RA professionals tend to be viewed as unsupportive and poor communicators. Again, just like being a business enabler, it’s about showing the stakeholders how they can benefit from your work. This is done through having personal relationships with them.

This should be done both internally and externally, “I can tell you all my QA/RA people, or most of them, have a great network with our customers.”

If you or your boss gets positive feedback as well from your customers, you don’t have to fight anymore to get your next year QARA budget or people needed, he might assign even more money to the QARA department because he realize the added value QARA is contributing.

If you are looking to hire business-minded QA/RA professionals that will help you achieve your business goals, get in touch with us at hello@elemed.eu

Say goodbye to wasting time and money on digitising your regulatory activities.


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