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Lead Quality Assurance Engineer

2 months ago

Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full time
Position Overview

Lead Quality Assurance Engineer – Manufacturing Quality (onsite)

At BrioHealth Solutions, we are committed to improving the lives of individuals with advanced heart failure through innovative technology and a strong culture of creativity. Our goal is to attract a diverse workforce that reflects the varied experiences of our patients and promotes a patient-focused approach.

This role is primarily based in Billerica, MA and may require occasional travel.

Primary Responsibilities

  • Supervise manufacturing quality by offering insights on product specifications, overseeing operational processes, and directing inspection activities.
  • Facilitate design transfer operations, working closely with Research & Development and Manufacturing Engineering teams.
  • Assist in process enhancement initiatives, resolve production challenges, and develop training programs.
  • Participate in supplier oversight activities, ensuring adherence to quality and compliance standards.
  • Collaborate across functions to promote continuous improvement and risk management strategies.

Qualifications

  • Bachelor's degree in Engineering or a related discipline.
  • A minimum of 5 years of experience in manufacturing quality or engineering within the medical device sector.

Desirable Skills

  • Advanced degree in Engineering.
  • Experience with Class III medical devices.
  • Certification as an ASQ Quality Engineer.
  • Lean/Six Sigma certification.
  • Thorough understanding of regulatory requirements and quality management systems.

About BrioHealth Solutions, Inc.

BrioHealth Solutions is a prominent player in the medical technology field, dedicated to delivering innovative solutions for patients with heart failure. Our team is focused on developing advanced therapies that enhance patient outcomes and improve access to life-saving treatments globally.