Quality Assurance Specialist

6 days ago


Natick, Massachusetts, United States Allurion Full time
About Allurion

We are a leading medical device company dedicated to transforming the way obesity is treated. Our mission is to make a lasting impact on the world by providing innovative solutions for a healthier future.

Job Summary

We are seeking a highly skilled Senior Quality Assurance Engineer to join our quality assurance team. As a key member of our team, you will play a vital role in ensuring the safety and success of our medical devices.

Key Responsibilities
  • Lead or contribute to significant projects, processes, or improvements within the quality assurance team.
  • Collaborate closely with key stakeholders, offering guidance and reviewing technical inputs and outputs for various tasks and projects.
  • Support the Manufacturing Quality Team by troubleshooting issues, conducting root cause investigations, and providing assistance as needed.
  • Guide R&D and manufacturing teams on verification, sampling plans, and usability testing to ensure compliance with internal and external requirements.
  • Provide expertise on relevant medical device standards and guide cross-functional teams toward compliance.
Requirements
  • Bachelor's degree in Engineering, Science, Quality Management, or a related technical field.
  • 5+ years of experience in medical device design, development, and manufacturing.
  • Demonstrated proficiency in specific areas of medical device engineering.
  • Proven track record of implementing process improvements.
  • Mastery of Quality Management System (QMS) standards.
  • Experience in developing and executing verification/validation protocols.
  • Strong statistics knowledge and data analysis skills.
  • Possession of auditing certification.
  • Previous experience working within a highly regulated industry, with particular emphasis on ISO 13485 and FDA regulations.
  • Excellent interpersonal and communication skills, with the ability to collaborate effectively within cross-functional teams.
What We Offer
  • Competitive package.
  • Paid time off.
  • Training and career development opportunities.
  • Global employee assistance program and total wellbeing platform.
  • Employee stock purchase program.
  • Volunteer time off.
Location and Work Arrangements

We offer a hybrid full-time schedule, with 4 days onsite. Our office is located in Natick, and we believe in the power of both virtual connections and in-person interactions, fostering a dynamic culture of collaboration and innovation across our diverse global team.



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