Quality and Compliance Engineer

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

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