Discover how Triple Ring Technologies turns science into commercial success. We co-develop breakthrough products and create new businesses.
About the role
The Manager of Quality Assurance will maintain and lead the implementation of Triple Ring’s Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development of hardware, software, and AI/ML-enabled systems, engineering builds, clinical builds, and transfer to manufacturing.
What they're looking for
- Expert in medical device design assurance activities, including design controls, risk management, software development lifecycle, design reviews, design transfer and medical device regulatory submissions
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred
- ISO 13485 – Lead Assessor Certification required. Other ASQ and RAPS Certifications are a plus (e.g., Certfifed Quality Auditor, Certified Quality Engineer, Certified Quality Manager-Operational Excellence)
- Experience hosting external audits and regulatory inspection as primary audit guide a must
- Strong understanding and application of the following medical device standards is required
- ISO14971:2019,
More about this role
Triple Ring Technologies, Inc. offers a unique environment for talented individuals interested in undertaking varied technical challenges, primarily in medical device and life science industries. Headquartered in Newark, CA, we are an innovative research and development company that partners with clients to deliver complex technical solutions. Our highly interdisciplinary team includes senior professionals from industry, finance, and academia, with extensive experience in medical device, life science, clean tech, security, and industrial technologies. We rely upon each other for technical excellence, real-world engineering and commercial wisdom. Learn more at www.tripleringtech.com .
The Manager of Quality Assurance will maintain and lead the implementation of Triple Ring’s Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development of hardware, software, and AI/ML-enabled systems, engineering builds, clinical builds, and transfer to...
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