QT Ultrasound is a cohort of exceptional talent from a variety of professional backgrounds. A collaboration of clinicians, engineers and scientists – it is the quintessential biomedical engineering and clinical trials company. If you want to join the best and brightest with a mission to transform the diagnostic assessment of breast health, we encourage you to apply.
Document Control Specialist
Apply Via Email
The Document Control Specialist will be responsible for initiating, editing, and controlling documents and records according to procedures, standards, and regulations in an FDA regulated environment. Responsibilities will include updating and filing documents, logs, and databases in support of QMS activities. The individual will coordinate the review and revision of procedures, specifications, and forms, as well as obtain approvals. Additionally, the individual will prepare and process status reports, assign and monitor document numbers, and review documents for accuracy and completeness. They will also be responsible for the maintenance of electronic files to support the documentation control system.
- Support the development of the document control system.
• Coordinate the review and revision of procedures, specifications, forms, and other meetings as assigned.
• Prepare reports, assign, and monitor QA document and part numbers, and review documents for accuracy and completeness.
• Maintain electronic and paper files to support document control system.
• File, retrieve, and maintain documents.
• Receive, review, control, and track documents per relevant process and procedures.
• Update and control documents, logs, and databases, while assigning part numbers and routing additions, deletions, and changes.
• Control engineering notebook distribution and retrieval.
• Identify and implement improvements to the document control system.
• Train personnel on document format, content, use, control, and the document control system.
• Support company goals, objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements.
• Actively work to promote team building and morale within the company.
• Perform other duties as assigned.
- Bachelor’s Degree of equivalent experience/education.
- Minimum 1+ years of related experience in the medical device industry.
- Preferred 3+ years of related experience in the medical device industry.
- Thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, PowerPoint and Project.
- Excellent verbal and written communication skills.
- Ability to work independently.
- Ability to build strong working relationships with multiple departments.
- Experience with Class II medical devices.
- Start-up experience highly preferred.
Field Service Engineer III
Apply Via LinkedIn
QT Ultrasound is seeking a Field Service Engineer (FSE III) to play a key role in the support of our new 3D Ultrasound breast imaging system. This position will be based in the San Francisco Bay area and will carry out some activities in our Novato facility when not in the field.
QT Ultrasound is a privately held medical technology company engaged in the research, development and commercialization of an innovative, FDA cleared, automated breast imaging system that produces the highest resolution, and only true 3D, transmission ultrasound images. We exist to change the paradigm of breast imaging, allowing for the early detection of breast cancer – with no radiation and no compression.
The Field Service Engineer III is an integral member of the QT Ultrasound Field Service and Customer Support team with customer facing responsibilities including installation, repair and preventive maintenance of ultrasound diagnostic imaging systems. Candidates for this position must be process and quality driven, while also possessing excellent troubleshooting and customer service skills. This position will require travel within the US, often on short notice (estimated at more than 50%, some overnight). Experience supporting ultrasound medical devices or other medical imaging capital equipment is preferred.
- Provides support to customers within the United States ensuring customer needs for service and support are met. Typically provides support Monday through Friday between the hours of 8AM to 6PM with some extended or on-call hours when necessary. Support may be provided via remote connection to products, over phone/text/email, or in-person at medical imaging facility.
- Must be able to work overtime when required and be flexible on daily start and stop times to support our customers including some evening and weekend work.
- Provides highly visible customer support through the performance of on-site repair. Serves as customer contact on technical and service related problems.
- Diagnose, troubleshoot, service, and repair high complexity ultrasound imaging systems.
- Communicates with product support, sales, tech support and other departments as needed to address customer concerns to ensure customer needs are met.
- Determines most cost-effective repair/resolution to minimize customer downtime.
- Works independently to schedule and perform Preventive Maintenance on existing instruments as assigned.
- Document all service work in accordance with procedures which may be subject to FDA inspection. Familiar with using CRM software to record customer interactions and work performed.
- Completes service reports upon work completion and submits report within 24 hours of call.
- Ensures communication/coordination of install scheduling with Customer Support, Sales and the Customer.
- Installs and tests new imaging systems using established installation and system verification procedures.
- Provides customer with basic operator training including start-up/shutdown procedures as well as making the customer aware of any safety precautions.
- Performs pre-installation site visits to ensure all system requirements can be met prior to installation.
- Maintains spare parts inventory and is responsible for inventory counts and accuracy.
- Escalates to other resources and/or management when unable to resolve a problem.
- Log potential software glitches/bugs for further analysis and review.
- Completes assigned training prior to date due.
- Manages expenses within company guidelines and submits timely expense reports.
- Maintains company supplied tools and test equipment in good working order and ensures calibrated tools are returned for calibration by date due.
- May be required to produce reports summarizing product failures and providing recommendations for product improvements.
- Performs other tasks and duties as assigned.
- AS or higher degree in an engineering related field and 5+ years of transferable field service experience servicing electro-mechanical/electronic/optical/robotics equipment in a biomedical engineering or a medical diagnostics instrumentation environment, or BS degree and 3+ years equivalent experience, or equivalent military experience.
- Experience servicing ultrasound systems is strongly desirable.
- Advanced electro-mechanical troubleshooting/problem solving skills.
- Self-driven with the ability to learn quickly to become proficient on products.
- Ability to troubleshoot software issues within a Linux environment.
- Advanced knowledge of computer networks supporting DICOM image storage and transfers and the ability to interact with IT departments to resolve network issues.
- Ability to work with in-house technical support resources to resolve difficult product problems.
- Excellent organizational, multitasking, and time management skills.
- Good customer relation and communication skills, both written and oral.
- Knowledge of on-site safety protocol in a laboratory environment.
- Ability to travel extensively on short notice; involves some overnight travel.
- Ability to lift, push and pull approximately 50 pounds unassisted.
- Ability to push and pull equipment on wheels or with aid of lift-jack weighing up to 1000 lbs.
- Involves reaching, sitting, standing, talking and hearing, close and distance vision, color vision, stooping, kneeling, crouching, pushing, pulling, and lifting.
- Possesses valid driver’s license, with no major infractions within the last 3 years