Job SummaryThe 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.
Responsibilities- 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.
- 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
- Oversee the generation and maintenance of quality records that are consistent with Triple Ring's QMS
- Ensure that quality records are maintained in a state of readiness for external audits and regulatory inspections
- 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
- Provide input to quality-related planning to meet short and long term business goals
- Provide management with objective evaluation of overall quality performance and guidance for implementation of improvements
- Actively participate in developing and deploying effective continuous improvement of Triple Ring's quality management processes
- Serve as the ISO13485:2016 QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary
- Manage Triple Ring's Document Control function and related personnel
Education, Experience, and Skills- Expert in medical device design assurance activities, including design controls, risk management, software development lifecycle, design reviews, design transfer and medical device regulatory submissions.
- Demonstrated hands-on experience personally executing and reviewing design assurance deliverables-design controls, Design History File (DHF) and requirements traceability, risk management, and verification and validation (V&V)-for hardware, software, and AI/ML-enabled medical devices; this is a hands-on technical role, not an oversight- or audit-only function.
- 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.
- ISO 13485:2016,
- ISO14971:2019,
- ISO/IEC62304:2006,
- IEC60601-1/IEC61010
- In-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy related to medical device development lifecycle, from ideation to commercial distribution.
- Previous experience collaborating with medical device submission, such as US FDA 510(K) and PMA is required.
- Demonstrated knowledge of interpretation and application of 21CFR820 QMSR. Understanding of EU-MDR and other MDSAP OUS regions a plus.
- Working understanding of GCP clinical investigation and validation activities.
- Minimum three (3) years of active medical device quality engineering or design assurance background, with additional 2 years of quality leadership experience;
- Strong Experience in design, manufacturing, process validation for medical devices or other technically complex or regulated products
- Working knowledge of engineering design and build practices
- Working knowledge of basic assembly and manufacturing processes
- Progressive QA/QC leadership experience, including "hands-on" detailed quality systems development and experience managing implementation of quality functions and related personnel
- Demonstrated leadership of design assurance across concurrent hardware, software, and AI/ML workstreams within a single device program, including setting strategy and reviewing deliverables produced by project engineers
- Experience implementing electronic Quality Management System (eQMS) and other relevant computer system validation (CSV) /computer system assurance (CSA) activities.
- Comfortable with electronic documentation/records systems (e.g., Windchill, Helix) and strong general office computing skills, including experience with creating Microsoft Office templates and using AI Tools.
Desired skills:- Hands-on experience standing up or maturing design assurance for AI/ML-enabled SaMD, including dataset and data-provenance controls, model verification and validation, and ongoing algorithm performance monitoring
- Experience defining and executing software and algorithm verification and validation (V&V) strategy traceable to design inputs, hazard analysis, and risk controls, including IEC 62304 software safety classification
- IEC 81001-5-1 (health software security) and AI/ML governance frameworks-FDA Good Machine Learning Practice (GMLP), AAMI CR34971/TR34971, and ISO/IEC 42001-a plus
- Previous direct medical device submission responsibility as primary sponsor is a plus
Our benefit program includes: flexible time off, paid holidays, 401(k) plan with employer match, bonus, equity, a variety of medical, dental and vision plan options, and more.
The annual salary range for jobs which are performed in US, California is $125,000 to $150,000. Please note that the salary range is a guideline and compensation may vary based on factors such as qualifications, skill level, experience, competencies and work location.
This role will be eligible for our hybrid work model which requires working onsite a minimum of 3 days per week: Tuesday, Wednesday, and 1-day of your choice. In certain circumstances the hybrid work model may change to accommodate business needs.
