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Description

The Quality and Compliance Engineer’s role is to work with the product engineering and regulatory teams to ensure quality management and regulatory compliance for FDA cleared products.

Responsibilities:

  • Maintain and update quality management system
  • Ensure compliance of design, development, testing and deployment documentation
  • Help oversee post-market feedback and CAPA procedures

Qualifications

Required:

  • BA/BS in Computer Science, Computer Engineering, Biomedical, or related technical field
  • 1-3 years working in a regulated industry (FDA and medical devices preferred)
  • Experience creating controlled documents for traceability and as objective evidence
  • Excellent organizational skills
  • Strong problem-solving ability and exceptional attention to detail
  • Ability to effectively manage multiple simultaneous tasks and priorities
  • Strong teamwork mindset, desire to learn and share information with others
  • Ability to maintain confidentiality and exercise good judgment
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple levels in the organization
  • Self-starter with a sharp focus on quality and customer experience

Preferred:

  • Master’s Degree in Engineering, Quality, Regulatory, or related
  • Experience with 510K or PMA submissions is very helpful
  • Prior experience with a programming language (e.g. C++, Python, Java) is very helpful
  • Experience with ISO 13485, ISO 14971, 21 CFR 820, IEC 62304
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Contact Us About This Position

We’re always looking for talented, motivated individuals to join our team – get in touch!