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Quality Engineer

Key Responsibilities:

• Support the QMS for a fast growth digital health company contributing to the cure of major diseases

• Directly support Supplier Qualification and continuous improvement for a digital health company

• Directly support CAPA, training, audit preparedness, and quality systems efficiencies in a digital health product development environment

• Support compliance in all phases of design and development, manufacture, and product release

 

Requirements:

Minimum of a bachelor’s degree in Mechanical, Aeronautical, Electronics or other related field

• At least 4 years of experience in a QMS role within the medical device, emerging medtech or digital health space. Other life sciences experience may be considered.

• Hands-on ability to work autonomously to problem-solve; excellent analytical and project management skills to help a growing company succeed.

• Experience and knowledge in application of 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971

• Superior verbal and oral communication skills and intellectual curiousity

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