Quality Assurance Engineer

1 week ago


Arden Hills, Minnesota, United States Boston Scientific Full time
About this Role:

As a Quality Assurance Engineer at Boston Scientific, you will play a critical role in ensuring the quality and performance of our medical devices. You will be responsible for investigating post-market complaints and signals, collaborating with cross-functional teams to identify and implement continuous improvements, and mentoring product investigators to resolve quality issues.

This is a safety-sensitive position, and candidates will be subject to a drug test as a pre-employment requirement. Boston Scientific is committed to maintaining a prohibited substance-free workplace.

Your Responsibilities:
  • Analyze customer complaints, events, and other post-market surveillance data to identify patterns and trends.
  • Conduct product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities.
  • Mentor product investigators by providing technical guidance in identifying and resolving quality issues.
  • Partner with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes.
  • Communicate product performance by formal presentations to management committees and design teams.
Requirements:
  • Bachelor's degree in engineering or a related technical/scientific discipline.
  • Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
  • Experience in the Medical Device industry or a Quality organization.
  • Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook.
About Boston Scientific:

Boston Scientific is a global leader in medical science, committed to advancing science for life. We are dedicated to solving the challenges that matter most, united by a deep caring for human life. Our mission is to create innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and is essential in our work of advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all.



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