Hands-on position working closely with the product development team to plan, establish and execute QA programs that comply with FDA Quality System Requirements (QSR) for medical devices. Continue the development and implementation of the company’s Quality Management System (QMS).
The candidate should have both knowledge and experience in Quality System (QS) Regulation/Medical Device Good Manufacturing Practices. CGMP requirements for devices in part 820 (21 CFR part 820)
Responsibilities Overview :
This candidate will Work in collaboration with the development team to ensure that all aspects of the Design Controls are fully met and appropriate regulatory, quality and reliability requirements are well defined, documented and implemented throughout the project phases.
The Quality Assurance Engineer primary role is to assist in the implementation and management of the document control function to include quality system procedures, forms, Design History File (DHF), Device Master Record documentation (DMR documentation), and Quality Record Management. This position additionally includes review of product DHRs and product release related to contract manufactured product as applicable, management and follow-up of open corrective/preventive actions and non-conformance reports (NCRs), assisting in the execution of internal audits, assisting in the facilitation of QA/RA related training as required, supporting annual management review, assisting in creating, reviewing and updating supplier files, and supporting external audits/inspections and regulatory affair submissions/product registrations and licensure as required.
- Manage the control of quality system documentation (procedures, work instructions, forms), DHF documentation, DMR documentation, DHR documentation, and quality records. This includes creating some of this documentation.
- Ensure complaint documentation and records are complete and in compliance with regulatory/quality requirements prior to closure.
- Review production device history records for accuracy and completeness, document the release of finished product from contract manufacturers as required.
- Support RA/QA management with CAPA review board forums, as deemed required and monitor completion of tasks, ensuring CAPA files remain updated as necessary Provide investigative support when product quality issues or adverse events arise and ensure proper analysis and documentation.
- Assist in executing internal audits and participate in and support external audits and inspections.
- Assist in facilitating RA/QA related training as required.
- Support and participate in annual management reviews.
- Create, review, and maintain supplier files and Approved Supplier List
- Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).
- Instruct, guide and facilitate the development team on the application of relevant regulations, design controls, applicable guidelines and product standards (e.g. IEC60601-1, IEC62304, ISO14971, IEC62366) and ensure evidence of conformity.
- Manage the Risk Analysis process. Conduct periodic/per case Risk Analysis reviews (Design, Use, process) and periodically update the relevant Documents and verify that all the required actions have been fully performed.
- Instruct and support the preparation of bench testing, Proof of Design (POD) processes, external laboratories testing, and technical reports to support regulatory submissions.
- Write and review documents for regulatory submissions (based on a regulatory strategy), review and approve test protocols and reports, review promotional material and labeling for regulatory compliance
- Write Validation protocols, Perform Validation testing, Write Validation Reports for Software and Device.
- Performs other related duties and responsibilities, as assigned
- At least 5 years of related experience in the medical device industry
- Bachelor’s degree in engineering, or equivalent experience (Biomedical or Quality Engineering – an advantage)
- Strong demonstrated working knowledge and experience in FDA QSR (21 CFR §820), EN/ISO 13485, and EN/ISO 14971
- ASQ CQE or other certifications a plus
- Direct experience managing all aspects of document control and quality records in a regulated industry
- Direct experience and knowledge of CAPA requirements and CAPA management
- Direct experience participating in and supporting internal audits and external inspections (for compliance with regulatory requirements including 21 CFR Part 820, ISO 13485, etc.)
- Strong communication skills (written, oral, and listening)
- Strong organizational and time management skills and ability to work independently as required
- Data management skills- database, Excel, familiarity with eQMS and ERP systems
Spectral MD, an early stage medical device company, is developing a diagnostic 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. Spectral MD is located in a modern high-rise office building in the heart of Uptown Dallas, TX. While we are small, we offer excellent employee benefits.