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Senior Quality Engineer

PathAI

PathAI

Quality Assurance
Boston, MA, USA · Remote
Posted on Thursday, September 14, 2023

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

This is not a testing role.

Where You Fit

We're looking for a software quality professional with at least 5 years’ experience in the Software Medical Device industry. As we are expanding our business and products, we are building the quality assurance team. In this role, you have the opportunity to contribute to growing the team and to developing your own challenging, rewarding career path.

What You'll Do:

  • If you're the right candidate, you'll be exercising all the skills you have in this role, and building new ones along the way, including:
  • Conducting software validations including plans, protocols and reports
  • Supporting the QMS
  • Supporting product development teams in the design of Software as a Medical Device
  • Serving as the consultant for engineering and manufacturing teams throughout the design control process
  • Supporting the compliance process in all phases of design and development, manufacture, and product release

What You'll Bring:

  • *Minimum bachelor’s degree in an appropriate scientific or other related field
  • At least 5 years’ experience in the software quality environment within the Medical Device industry
  • Hands-on ability to work autonomously to problem-solve, demonstrating excellent analytical skills
  • Experience with implementation of ISO 62304
  • Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971
  • An insatiable intellectual curiosity and the ability to learn quickly in a complex space and help to shape the regulatory team
  • Excellent verbal and oral communication skills

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

PathAI does not accept unsolicited submissions from third-parties.

With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.