Quality Systems Engineer

2 weeks ago


Manchester, New Hampshire, United States DEKA Research & Development Full time
Quality Systems Engineer

At DEKA Research & Development, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our quality team, you will play a critical role in ensuring the highest standards of quality and compliance in our software development processes.

Key Responsibilities:
  • Develop and revise Standard Operating Procedures (SOPs) and associated change controls to ensure alignment with regulatory requirements.
  • Lead collaborative efforts to drive internal investigations and improvements, ensuring comprehensive analysis and appropriate solutions are implemented by cross-functional teams.
  • Ensure compliance with FDA Part 820 and ISO 13485 regulatory standards, maintaining the integrity and effectiveness of the DEKA QMS.
  • Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.
Requirements:
  • BS/MS in Science or Engineering
  • Preferred 2+ years' experience in quality systems management, medical device, or a similar regulated environment
  • Experience with software development (medical device preferred)
  • Strong written/verbal communication skills
  • Excel, Word, Visio skills
  • Technical writing experience
  • Project coordination/management skills
  • Aptitude for learning technical information
About DEKA:

DEKA Research & Development is a leading innovator in the field of medical device development. Our team of professionals strives to make a difference every day through thoughtful engineering, design, and manufacturing. We are committed to creating innovative and life-changing products that improve the lives of our customers.



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