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Job Requirements
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.
Role Summary
The Quality System Specialist I (QSS I) is an entry-level to intermediate position responsible for maintaining and improving Quality Management Systems (QMS) to ensure compliance with ISO 13485, FDA QSR, and other relevant regulations. Reporting to the RA/QA Director, the QSS I collaborates with cross-functional teams to support document control, CAPA management, and regulatory compliance, while also assisting with quality audits and SOP development.
Responsibilities
• Coordinate activities of TeraRecon’s Quality Management System, this can include but may not be limited to the following:
• Document Control Coordinator: Ensure documents for release follow TeraRecon’s document control and record control procedures
• Training Coordinator: Ensure required training is assigned appropriately to individuals and it is being completed
• Corrective and Preventative Action Coordinator: Track execution of corrective and preventative actions and ensure they follow TeraRecon’s procedure
• Non-Conformance Coordinator: Track execution of non-conformances and ensure they follow TeraRecon’s procedure
• Internal Audits: Track execution of internal audits per the defined Internal Audit Schedule to ensure that they follow TeraRecon’s procedure
• Monitor TeraRecon’s Quality Management System process and provide insight on the business’ compliance to the QMS, this can include but may not be limited to the following:
• Develop process monitoring metrics to determine compliance to TeraRecon’s Quality Management System and identify activities which need attention to meet defined planned goals and potential areas of non-conformance to correct prior to systemic issues developing.
• Execute the processes defined by TeraRecon’s Quality Management System, this can include but may not be limited to the following:
• Document Control: Review and approve documentation which you are assigned as the subject matter expert. Share knowledge and train company employees on how to follow TeraRecon’s document control process utilizing any tools that TeraRecon as in place to facilitate the process.
• Training: Determine and document training requirements for documents utilized in TeraRecon’s Quality Management System. Set-up and execute training working cross functionally as required to determine training needs and competency assessments.
• Corrective and Preventative Actions: Execute CAPA investigations, root cause assessments, corrective action plans and effectiveness verifications.
• Non-Conformances: Execute Non-Conformance investigations, determine appropriate dispositions for non-conforming product, and execute corrective action plan.
• Internal Audits: Execute in conjunction with a lead auditor internal audits per TeraRecon’s defined internal audit schedule. Develop the audit plan, propose non-conformances and opportunities for improvement to be discussed by the audit team, and document areas of conformity showing how the business is compliant to its Quality Management System.
• Design Control and Change Control: Draft, author, review, and/or approve design control and change control deliverables which are generated through execution of design projects following TeraRecon’s defined procedures.
• Computer System Validation: Author, review, and/or approve deliverables generated from execution of computer system validation projects at TeraRecon to move to production use systems which are utilized by the business in development and surveillance of a medical device pre- and post-market.
• Process Validation: Author, review, and/or approve deliverables required to validate processes which are utilized by TeraRecon in development and surveillance of a medical device pre- and post- market.
• Supplier Management: Establish supplier controls and approve suppliers which TeraRecon can then utilize for QMS governed activities.
Requirements
• Completion of an undergraduate degree (preferably a Bachelor of Science in an engineering discipline such as Biomedical Engineering or System Engineering), work experience can substitute for degree requirement
• Minimum 3-4 years working as part of a Quality Team at a medical device manufacturer, with experience executing at least two of the following Quality Management System processes: Document Control, Training, Corrective and Preventive Actions, Non-Conformances, Internal Audits, Design Control and Change Control, Computer System Validation, and/ or Process Validation.
• Knowledge and experience of working in a QMS which has processes compliant to ISO 13485, ISO 14971, IEC 62304 (prefer knowledge and experience with IEC 82304 and IEC 62366 in addition), and FDA’s Quality System Regulation.
• Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and CE Marking).
• Participate in Internal and External audits.
• Understand and practice all requirements of EN ISO 13485, ISO 13485, TeraRecon QMS Manual, Process Flows and Work Instructions.
• Familiarity with software development processes in regulated environments, particularly medical device software.
• Basic understanding of regulatory frameworks for medical devices, including FDA, EU MDR, and other international requirements.
• Ability to interpret regulatory guidelines and apply them within the QMS.
• Strong problem-solving skills to identify and resolve quality issues effectively.
• Strong written and verbal communication skills for internal coordination and external regulatory interactions.
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.
