Quality Assurance Manager

About the role

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.

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 ISO13485:2016 QMS 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.

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.
• 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 ISO13485:2016 QMS 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.

Requirements

• 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.
• Demonstrated knowledge of interpretation and application of 21CFR820 QMSR. Understanding of EU-MDR and other MDSAP OUS regions a plus.
• 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.
• 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.
• 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
• 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

Qualifications

• 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.
• Demonstrated knowledge of interpretation and application of 21CFR820 QMSR. Understanding of EU-MDR and other MDSAP OUS regions a plus.
• 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.
• 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.
• 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
• 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

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,ISO149