Medical Device Quality Systems Expert

4 days ago


Boston, Massachusetts, United States RQMIS Inc Full time
Job Overview

We are seeking a highly skilled Medical Device Quality Systems Expert to join our team at RQMIS Inc. Based in the north of Boston, Massachusetts area, we provide strategic guidance to companies navigating FDA, UK, and EU regulations.

About the Role

The ideal candidate will have a strong background in medical device and combination product regulations, with experience in software quality system design and management. As a Regulatory Compliance Specialist - Software Development, you will assist clients in ensuring compliance with relevant regulations, including GMPs, QSR, ISO 9001, and IEC 62304.

This is a full-time position that offers a competitive salary of $120,000 per annum, based on industry standards and location. You will also enjoy a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Responsibilities
  • Assist clients in implementing software quality systems that meet regulatory requirements.
  • Audit client quality systems to ensure compliance with FDA's QSR, ISO 13485, and other regulations.
  • Develop and implement tools for employees to conduct their activities efficiently.
  • Design and implement IQ/OQ/PQ for client equipment and processes.
Requirements
  • Bachelor's degree in computer science, engineering, or a scientific field.
  • 6-10 years' experience in drug, biologics, tissue regulations, and standards.
  • Strong attention to detail, computer skills, and leadership abilities.
Work Environment

The work environment is moderate noise level, with occasional travel required. The company offers a dynamic and fast-growing environment with opportunities for professional growth.



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