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Quality Assurance Specialist

2 months ago

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

RQMIS, Inc. is on the lookout for a Quality Assurance Specialist who will play a pivotal role in our team. This position is focused on working closely with consultants to manage projects that pertain to regulatory submissions, quality management documentation, and clinical research materials.

Core Responsibilities:

  • Assist clients in the design and management of quality systems and Change Controls
  • Ensure adherence to medical device regulations including ISO13485, QSR (FDA), and MDR/IVDR
  • Develop and uphold quality system procedures and documentation
  • Contribute to the manufacturing sections of regulatory submissions
  • Provide regulatory insights and support during inspections and audits
  • Implement tools for employee engagement and client training initiatives

Qualifications:

  • Bachelor's degree in engineering or a related discipline
  • 4-6 years of experience in medical device regulations
  • Exceptional attention to detail and proficiency in computer skills
  • Strong communication and leadership capabilities
  • Ability to handle multiple tasks and prioritize effectively

Physical Demands:

  • Involves standing, sitting, reaching, and light lifting
  • Close vision required for computer tasks and manufacturing oversight
  • Regular attendance and adaptability to various work environments

Travel Requirements: Minimal travel expected, less than 25%

About RQMIS, Inc.

RQMIS, Inc. is a dynamic consultancy dedicated to regulatory strategy, clinical study design, and compliance with quality systems. With over 25 years of industry experience, we offer expert guidance on FDA, UK, and EU regulations to organizations around the globe.