Senior Quality Engineer

Work Level: FullTime

Position Summary: 

The Senior Biomedical Quality Engineer supports and maintains Quality Management System (QMS) activities, regulatory compliance, and cross-functional quality operations within a regulated medical device environment, ensuring effective quality processes, documentation control, audit readiness, and continuous improvement.

Essential Duties and Responsibilities:

• Maintain and manage QMS documentation including procedures, SOPs, work instructions, forms, policies, and Quality Manual records to ensure compliance and document control. 
• Support Change Control activities for product, manufacturing, software, and QMS changes, including impact assessments, traceability, and regulatory compliance. 
• Represent Quality in cross-functional meetings and provide quality guidance throughout product development and operational activities. 
• Support supplier quality activities including supplier qualification, evaluation, ASL management, supplier monitoring, and audit support. 
• Participate in internal, external, supplier, and regulatory audits including audit preparation, checklist development, mock audits, audit execution, and follow-up activities. 
• Review and maintain production and post-production records to ensure documentation accuracy, traceability, and audit readiness. 
• Support Design Control and Design History File (DHF) activities by organizing and maintaining hardware, software, and AI-related design documentation and deliverables. 
• Manage QMS training activities including training assignments, records, effectiveness monitoring, training events, and compliance tracking. 
• Support Computer System Validation (CSV) activities including validation planning, testing, documentation, periodic review, and revalidation of computerized systems. 
• Manage equipment calibration activities including Master Equipment List (MEL) maintenance, calibration tracking, equipment logs, and external calibration coordination. 
• Manage Non-Conformance and Deviation processes including documentation, investigation, disposition, tracking, and closure activities. 
• Manage Complaint Handling, feedback, and CAPA activities including investigations, root cause analysis, corrective actions, effectiveness verification, and closure activities. 
• Monitor and analyze quality metrics, quality events, training compliance, audits, CAPAs, complaints, and operational quality activities using reporting and data analysis tools. 
• Develop and maintain dashboards, automated trackers, reports, and workflow tools to support process visibility, monitoring, and data-driven decision making. 
• Identify and support continuous improvement initiatives to enhance process efficiency, compliance, operational effectiveness, and risk reduction.

Qualifications:

Required Education and Experience

• Bachelor’s degree or advanced degree in Biomedical Engineering, Engineering, Biotechnology, Life Sciences, Quality, or related technical field; or equivalent experience. 
• 8 plus years of experience in medical device quality assurance, quality systems, document control, product development support, or related regulated industry functions. 
• Experience working in regulated medical device environments supporting FDA, ISO, and international regulatory compliance. 
• Experience supporting cross-functional teams involving hardware, software, manufacturing, and quality system activities. 

Knowledge, Skills, and Abilities

• Working knowledge of applicable medical device regulations and standards including FDA 21 CFR Part 820/QMSR, ISO 13485:2016, EU MDR 2017/745, EU MDD 93/42/EEC, ISO 14971:2019, IEC 62304, IEC 60601, and Human Factors/Usability Engineering principles. 
• Experience with data analysis, visualization, scripting, workflow automation, and dashboard/reporting tools (e.g., Excel, Power BI, or similar platforms) to develop tracking systems and process improvements supporting quality system monitoring, reporting efficiency, and data management activities. 
• Experience utilizing Electronic Quality Management Systems (eQMS) to manage controlled documentation, training records, workflows, and quality events within regulated environments.

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; and reach with hands and arms. 
• The employee is occasionally required to walk; sit; stoop, kneel, crouch, or crawl; and talk or hear.
• The employee is occasionally required to lift, carry, push or pull objects exerting up to 50 lbs. of force occasionally and/or up to 30 lbs. of force on a continual basis. 
• Specific vision abilities required by this job include ability to visually locate and inspect small parts and assemble parts at close distances.
• The employee requires the ability to perceive attributes of objects, such as size, shape, or texture by touch. 

Travel: 

Up to 5% of travel time expected for the position.

Equal Employment Opportunity:

Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.