Senior Quality Assurance Engineer

OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries of previous solutions by improving image quality, reducing radiation exposure, improving ease of use, and building solutions to deliver care outside of traditional scenarios. We enable anyone anywhere to access radiologic diagnostics at the point of need, expanding availability and changing how healthcare is delivered.

OXOS Medical is constantly innovating, building on our best-in-class imaging device, and expanding into cloud-based imaging platforms, robotic guided imaging, intraoperative computed tomography, and telemedical solutions. OXOS Medical has raised $26M from prominent MedTech investors, venture capital firms, and renowned orthopedic surgeons.

OXOS is searching for a Senior Quality Assurance Engineer to drive the fourth and fifth phases of the cycle quickly and efficiently to drive the commercialization of OXOS products and to maintain OXOS’s lead in radiographic technology. The Senior QA Engineer will spearhead engineering quality throughout every stage of product development. Engineering Quality encompasses the deployment and upkeep of the OXOS Quality Management System, ensuring product adherence to rigorous validation, verification, and implementation standards while fostering a culture of perpetual improvement, optimizing efficiency, minimizing defects, and elevating customer satisfaction.

Responsibilities

Support the design control process to ensure that OXOS devices and software meets or exceeds quality standards, leading to reliable and safe X-ray products.

• Design and enforce design control processes to demonstrate compliance with regulatory requirements set forth by the FDA, ISO 13485, and IEC.
• Generate meticulous documentation of design inputs, design outputs, verification and validation activities, providing evidence to demonstrate regulatory and customer compliance
• Execute systematic identification, assessment, and mitigation of potential risks associated with product design, reducing the chances of harm.
• Establish a framework for traceability, ensuring that design decisions, changes, and verification/validation activities are documented, providing accountability and enabling effective post-market surveillance, maintenance, and continuous improvement efforts.
• Foster excellence in engineering quality and address emerging issues in advance to execute a seamless transition from design to manufacturing.
• Create high-quality and robust engineering documentation and device records to facilitate swift regulatory approval.
• Preemptively detect and rectify potential problems to reduce time to market.
• Ensure all OXOS products are reliable, safe, and effective devices to drive enhanced customer satisfaction and superior patient outcomes.
• Cost Efficiency: Early detection and resolution of potential issues through quality engineering prevent costly recalls, reworks, and delays, promoting cost efficiency.
• Bolster OXOS’s brand reputation by promoting reliability and excellence and strengthening OXOS’ position in the market.
• Ensure all processes align with ISO 13485 standards, meticulously documenting and regularly updating both production and post-production activities.
• Implement regular employee training and workshops to ingrain ISO 13485 requirements within the organization,  and clarifying individual responsibilities within the QMS.
• Conduct routine internal audits to check ISO 13485 compliance, and adeptly manage external audits by regulatory or certification bodies.
• Execute the CAPA process, managing non-conformities by conducting root cause analyses, implementing corrective and preventive measures, and verifying their effectiveness.

Required Qualifications

• 4+ years of experience in Quality in an FDA-regulated medical device industry.
• Advanced knowledge of ISO 13485, Design Controls (Phase 1-5), and other relevant standards are crucial for ensuring compliance and developing safe, effective products.
• Exposure to MDSAP.
• Working knowledge of IEC 62304, ISO 14971, dFMEA, and pFMEA.
• In-depth knowledge of QC/QA activities and regulatory requirements in the medical device industry, preferably medical electrical equipment.
• Advanced knowledge of CAPA and NCR investigations.
• Attention to detail.
• Must understand complex systems, solve challenging problems, and make informed decisions that uphold product quality and safety.
• Must be able to optimize processes, reduce waste, meet tight deadlines, and contribute to the company's agile response to rapid change