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Elizabeth Herman

@elizabethherman

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I lead quality and engineering for active implantable medical device development and manufacturing.

United States

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What I'm looking for

I'm seeking opportunities to support critical business objectives and ensure the success of a Quality Management System, applying my quality and engineering leadership in active implantable medical devices.

At Glucotrack, I lead quality and engineering for product and process development, manufacturing readiness, and QMS compliance for active implantable medical devices.

I've guided design controls, risk management, DHF and DMR development, supplier quality, CAPA, complaint handling, validation strategies, and regulatory registrations including ISO 13485 and FDA requirements. I also provide technical oversight from product requirements through verification, validation, design transfer, and scalable commercial production while managing CMO and CDOs.

Previously, I led quality organizations at TOMZ and Cirtec Medical, improving manufacturing scrap from 8.19% to 1.8%, increasing stockroom capacity by 15%, and reducing annual NCMR generation by 20%.

Experience

Work history, roles, and key accomplishments

Current

Vice President, Quality

Current

Glucotrack

Jun 2026 - Present (3 months)

Provide Quality and technical Engineering leadership to ensure product and process development activities are standardized, established and scalable to accomplish Glucotrack design/development and manufacturing objectives while maintaining compliance to Glucotrack's QMS.

ISO 13485 FDA Design Control Risk Management FMEA CAPA Supplier Quality Internal Auditing Complaint Handling Document Control Training Metrology Calibration GDP GMP Project Management Contract Manufacturing

Director of Quality

Glucotrack

Jan 2025 - May 2026 (1 year 4 months)

Provided Quality leadership to ensure compliance with QMS and regulatory requirements, overseeing quality functions and continuous improvement.

ISO 13485 FDA Design Control Risk Management CAPA Supplier Quality Internal Auditing Complaint Handling Document Control Training Metrology Calibration GDP GMP

Director of Engineering

Glucotrack

Apr 2024 - Dec 2024 (8 months)

Provided technical engineering leadership to ensure product and process development activities are standardized, established and scalable to accomplish Glucotrack design/development and manufacturing objectives.

Design Control Risk Management FMEA Process Validation Method Development Supplier Quality Project Management Contract Manufacturing

Quality and Engineering Consultant

Brookview Consulting

Oct 2023 - May 2024 (7 months)

Provided professional services and recommendations on industry best practices for the medical device industry, including QMS implementations, design control, and supplier qualification.

QMS Implementation Design Control Product Lifecycle Management Design Transfer (DMR DHR)Supplier Qualification PLM ERP Validation CAPA Internal Audit ISO 13485

Sr. Quality Manager

Tomz Corporation

May 2021 - Dec 2023 (2 years 7 months)

Led and managed Quality-organizational personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System (QMS).

ISO 13485 FDA QMS CAPA Supplier Quality Internal Auditing Complaint Handling Document Control Training Metrology Calibration GDP GMP Risk Management FMEA Process Validation

Quality Manager

Tomz Corporation

Sep 2020 - May 2021 (8 months)

Managed Quality-organizational personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System (QMS).

ISO 13485 FDA QMS CAPA Supplier Quality Internal Auditing Complaint Handling Document Control Training Metrology Calibration GDP GMP Risk Management FMEA Process Validation

Principal Quality Engineer - D&D

Cirtec Medical

Apr 2019 - Jul 2020 (1 year 3 months)

Drove engineering product development teams to accomplish Phase Gate milestones, authored Phase Gate and Technical Design Review documentation, and developed design input/output mapping plans and design validation requirements based on user risk.

Design Control Phase Gates Risk Management FMEA Validation Verification Sampling Plans Test Method Validation Gage R&R Incoming inspection First Article Inspection CAPA COPQ NCMR Audit Project Management

Quality Engineer

Cirtec Medical

Apr 2016 - Apr 2019 (3 years)

Worked on multi-disciplinary teams while managing daily objectives to meet weekly, monthly, and quarterly deadlines, ensuring compliance to all internal and industry requirements for class III, active implantable medical devices.

Process Validation Quality Assurance Plans Risk Management FMEA Statistical Process Control CAPA Complaint Handling Incoming inspection MRB Root Cause Analysis Vendor Management Audit ERP Minitab

Manufacturing Engineering Intern

Cirtec Medical

Apr 2015 - Apr 2016 (1 year)

Worked under a Manufacturing Engineer to update the Design History File (DHF) for sustained manufacturing lines, coordinated team to quantify consumable order quantity and demand to implement Kan Ban system, and generated equipment validation protocols.