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Job ID: 7574
Job Title: Quality Operations Specialist
Location: Greater Boston, MA

My client is an innovative, commercial-stage medical device company committed to empowering patients to make informed treatment decisions. By leveraging cutting-edge technology and forward-thinking innovation, they aim to transform the healthcare experience. They focus on delivering solutions that enhance patient outcomes, streamline provider workflows, and address critical needs across diverse therapeutic areas.

Position Overview: The Quality Operations Specialist is responsible and accountable for ensuring that Customers’ and Patients’ needs are met and that devices released to the market conform to specifications. This role will focus on supporting, maintaining, and improving Quality Operations in accordance with applicable requirements of ISO13485, 21CFR820, and other defined compliance/business requirements.

Responsibilities:

  • Product acceptance activities, including DHR Review and Incoming Inspection.
  • Quality inspections relating to servicing of medical device products, including Preventive Maintenance.
  • Nonconformance handling.
  • Support of Corrective and Preventive Action (CAPA) Investigations, Action Planning, and Action Implementation.
  • Qualification and monitoring of production equipment, including managing calibration services.
  • Creation, implementation, maintenance, and continuous improvement of quality system processes and procedures.

Requirements:

  • A bachelor’s degree in a related field (e.g., engineering or science) is preferred.
  • 3 years of experience in Quality Operations or a related medical device role.
  • Strong knowledge of regulatory requirements, including ISO 13485, 21 CFR Part 820, and 21 CFR Part 803.
  • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and experience with electronic document management systems.
  • Strong analytical, organizational, and communication skills.
  • Ability to work independently and collaboratively in a fast-paced environment.