Job Posting | ConcertAI

Raleigh-Durham, North Carolina / TeraRecon - Regulatory Affairs / Full-Time

Quality Engineer Specialist

Company Overview

TeraRecon is a leader in advanced visualization and artificial intelligence solutions, our flagship product, Intuition, is the market share leader for radiology and cardiology advanced visualization. TeraRecon was also named the 2020 & 2021 KLAS category leader for advanced visualization and #1 in market share for radiology 3D solutions. We are committed to redefining advanced visualization by leveraging machine learning and improving radiology workflow through personalized automation that increases efficiency. TeraRecon is a privately held global company with its world headquarters in Durham, NC, and major offices in Tokyo, Japan; Frankfurt, Germany; Acton, MA; and Fremont, CA. While our employees are located worldwide, we work as one company, functionally aligned and goal driven. TeraRecon’s transparency and collaborative work environment foster an energetic and inviting family-like culture.

TeraRecon’s growth is due in large part to our highly sophisticated products and services. By offering some of the most advanced user-friendly healthcare solutions fueled with our innovative AI technology, we can continue our growth by commercializing relevant products that exceed our customer’s expectations. TeraRecon will continue its dedication to the development of clinically relevant and outcome-focused healthcare solutions utilizing skilled and innovative thinkers and doers who can build and execute using tools and processes for optimal product delivery.

Responsibilities

Software Quality Risk Management
- Assess, improve, and maintain Post Market Risk Management activities including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction
- Performs risk assessments for Defect Tracking Support, change control, & CAPAs
Software Development Life Cycle (SDLC) and Quality Management System (QMS)
- Investigate software quality and compliance issues (e.g., corrective and preventative actions, non-conformances, audit observations, software defects) for processes and products prior to final release based on engineering principles; identify problem statement, analyze results, make recommendations, and develop reports.
- Review and provide recommendations to continuous improvements of the Software as a Medical Device (SaMD) SDLC with key stakeholders, including but not limited to Design Validation, Risk Management, and Human Factors Engineering
- Review and approve project deliverables for assigned design control projects
- Assemble Design History Files, Device History Record and Device Master Records in electronic QMS for assigned design control projects
- Support internal and external audits

Requirements

Bachelor's Degree in Quality Engineering, Scientific (e.g. Biomedical Engineering), or related fields required or equivalent experience
1-3 years of relevant experience in Software Quality or Software Development or V&V (Verification and Validation) and Risk Management product life-cycle in a team-oriented environment
Experience working within and developing QMS in compliance with IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11, EU MDR, MDSAP
Ability to work on numerous projects in parallel
Must be a strong communicator with peers, team members, and management
Medical Device industry experience
Experience with Requirements Management preferred
Experience with Machine Learning preferred
Experience in software maintenance life phase preferred
Experience in internal auditing preferred

Salary: Salary/Depending on qualifications and experience.

Benefits: Medical, Dental, Vision, Life Insurance, LTD, STD, Section 125, and 401K with company match.

Learn More About TeraRecon

Serving 1,300 clinical sites globally, TeraRecon - a ConcertAI company - is a Best in KLAS solution provider for AI-empowered radiology, oncology, cardiology, neurology, and vascular surgery. Awarded the 2020 & 2021 KLAS Category Leader for Advanced Visualization, TeraRecon solutions are independent of any one manufacturer’s imaging equipment or PACS system, allowing a single, unified, and simplified clinical workflow that can improve efficiencies and deliver actionable physician-guided insights. In the future, the combination with ConcertAI could bring a single, advanced AI-augmented diagnosis and interpretation capability from clinical trials to patient care. Join us on our quest to create a world free of disease. Learn more about TeraRecon at www.terarecon.com , or follow us on LinkedIn.

EEO

TeraRecon is an equal opportunity employer and a Federal subcontractor. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or veteran status. For more information, please refer to the “EEO is the Law” poster.

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