Triple Ring Technologies

Manager, Quality Assurance

Newark, California, United States

Sponsorship not specified$125k-$150kDetected 25 days ago

GCPMachine LearningFDA RegulatoryMedical DevicesResearchLeadershipMicrosoft Office

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.

Provide project teams with the guidance necessary to maintain a high level of ISO13485:2016 QMS compliance, with specific focus on hardware, software and system design assurance activities.
Maintain and regularly update Triple Ring's library of applicable technical, quality, and risk management standards
Maintain Triple Ring's ISO13485:2016 certification, including managing and conducting internal audits
Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to ISO13485:2016 quality management systems
Support and manage ISO13485:2016QMS related training and professional development for Triple Ring scientific and technical staff
Own the Management Review process, managing and reporting project and operational quality metrics to management
Actively participate in developing and deploying effective continuous improvement of Triple Ring's quality management processes

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)

Previous direct medical device submission responsibility as primary sponsor is a plus
The annual salary range for jobs which are performed in US, California is $125,000 to $150,000.
In certain circumstances the hybrid work model may change to accommodate business needs.
If reasonable accommodation is needed to participate in the job application or interview process, please email staffing@tripleringtech.com.
Learn more at www.tripleringtech.com.

The annual salary range for jobs which are performed in US, California is $125,000 to $150,000.

Ensure that medical device design project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed
Ensure that medical device design project quality activities are efficient and effective and performed in a proactive manner

Previous direct medical device submission responsibility as primary sponsor is a plus

This listing is sourced directly from Triple Ring Technologies's careers page and normalized into a canonical job model.