Quality Assurance Teams and Building a Foundation of Trust

with Spencer Zawasky and Trisha Bouthot
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Sunrise Labs’ Spencer Zawasky, Principal Quality Engineer and Test Manager, and Trisha Bouthot, Director of Quality & Test, spoke about the importance of building a foundation of trust within quality assurance teams and with clients.

Bouthot said there are many factors involved to build a foundation of trust within a quality assurance team. Idea and knowledge sharing are critical components in this team trust formula.

“As an organization, we share a lot of knowledge. We have many lunch and learns and technical sharing sessions. And as a quality department, we meet multiple times a week and share in our experiences. There is so much power in knowledge transfer,” Bouthot said. “It really helps our team to be efficient.”

Empowerment is another element Bouthot said helps build trust within a team.

“Allowing people within a team to own their tasks and own their responsibilities puts forth a better product,” Bouthot said, “than they would if it was, say, me directing them to do something my way. I feel like it’s my job to guide them and remove obstacles for them so that they can be much more productive.”

Trust built the medical device industry.

“A quality assurance team enforces that trust,” Zawasky said. “We’re the ones who have to honor that trust in a way I don’t think is quite as prominent to the developers in an organization.”

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To learn more about what the FDA cares primarily about in reviewing medical devices: Safety and Efficacy, read our blog: 'Gaining Regulatory Approval' .

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