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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