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Principal Quality Engineer

4 months ago

Boerne, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Contribute significantly to the Quality Assurance function, providing leadership in quality processes throughout the product lifecycle. Drive the Risk Management process and associated activities. Collaborate with R&D Engineering to ensure proper documentation and compliance with relevant regulations and standards (21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, etc.). Support the Software Engineering function in implementing software development processes and managing software issues throughout the product lifecycle. uthor and review documentation for the DHF, DMR, Technical Documentation, and other essential files. Play a key role in reviewing Design Transfer and Product Launch, including change assessment activities. Contribute significantly to the development of EDMS as the Subject Matter Expert. Drive the implementation of new modules within the EDMS. Provide ongoing training and support to the company regarding the EDMS. ssist with Internal Audits as a qualified auditor/lead auditor. Participate in External Audits as a key member of the Quality Team. Identify and drive continuous improvement of the QMS. Develop strategy and provide internal guidance related to regulatory trends. Conduct trainings and communicate relevant materials to enhance the team's/company's understanding of working in a regulated environment. Requiremets: Bachelor's degree in life science or engineering. Minimum 10 years of medical device quality assurance experience, including at least 5 years in design assurance. Experience supporting regulatory submissions to FDA for medical devices (Class III preferred). Expertise in reviewing mechanical, software, and electronics design requirements and specifications. Proficient in the application of medical device design controls. Hands-on experience with medical device hardware and software lifecycle processes and risk management, including verification and validation activities. Current and working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62304, and EU MDR. Excellent documentation skills, including record maintenance/tracking and an understanding of document traceability.