Managing and monitoring of non-conformances and corrective and preventive actions (NCRs and CAPAs) including root cause analysis, problem-solving, continuous improvement and related corrective and preventive action as they relate to complaints, non-conforming material, and other quality data.
Ensure adherence to Purchasing Controls by performing supplier surveys, pre-assessment qualifications, managing of Supplier files and Approved Supplier List including tracking/trending of Supplier Quality Ratings.
Managing the Equipment/tooling system required for device development, testing and manufacturing.
Collaborating closely with a fast-paced product development team during all stages of device development.
Quality Assurance representative in the development teams to support development, review/approval and implementation of engineering specifications, device design & development documents including verification and validation protocols and reports.
Assist in activities and implementation of documents related to Risk Management per ISO 14971.
Development and/or review and approval of various procedures and work instructions to ensure compliance.
Reviewing and approving Engineering Change Orders.
Reviewing, processing and filing of various QMS and design and development documents according to Document Control/GMP requirements.
Monitoring, trending and reporting of internal and external quality problems.
Prepare, file, monitor and maintain Personnel Training records and matrices
Supporting internal and external quality audits.
Assist in the preparation of Quality Systems metrics to track performance and compliance for Management Review.
Assist in and/or performing Internal Audits of the Quality Management System.
Assist in other quality systems responsibilities to ensure continuous compliance of Quality Management System.
Minimum of 3 years of experience in regulated industry, preferably in Medical Devices
Familiarity with 21 CFR 820, ISO 13485, ISO 14971, ISO 60601
Bachelor’s degree in Biomedical Engineering, Quality Engineering, Computer Science/Engineering, or related field
Working knowledge of the Microsoft office suite of products (PowerPoint, Excel)
Must be able to effectively articulate (verbally and in writing) quality related results and conclusions to technical and non-technical personnel
Must have strong documentation skills
Must take initiative and has the ability to conduct hands-on work
Must possess the ability to handle multiple tasks with high attention to detail
About Spectral MD
Spectral MD, a mid-stage medical device company, is developing a diagnostic imaging device from visible and infrared images of burns, chronic wounds, and other pathological conditions of the skin. We focus on image processing and machine learning of digital biological images to help clinicians make better and faster treatment decisions. Preliminary clinical studies are running in multiple applications of the device, especially: burn wound diagnosis; diabetic foot ulcer assessment; and lower extremity amputation site selection. Spectral MD is located in a modern high-rise office building in the heart of Uptown Dallas, TX.