quality engineer, staff

Confluent Medical • Austin, TX

4d

About The Position

Confluent Medical Technologies is seeking a Quality Assurance Engineer to join its Austin, Texas team. The company collaborates with customers to take medical-device projects from rapid prototyping through high-volume production, drawing on expertise in material science, engineering, and manufacturing. Its capabilities include Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.

In this role, you will help ensure that design and development projects meet customer, risk-management, quality, and design-control requirements and support successful transfer of designs to manufacturing. You will work on moderately to highly complex problems, applying knowledge of industry regulations and best practices, analysis, and critical thinking. You will contribute to decisions about project scope, materials, equipment, testing methods, task duration, and design changes.

Requirements

• Bachelor of Science in a related engineering discipline and 5 years of related Quality experience in a medical-device environment, or an equivalent combination of education and experience; alternatively, a master's degree in a related engineering discipline and 3 years of related Quality experience in a medical-device environment, or an equivalent combination of education and experience.
• At least 3 years of experience in medical-device product development.
• At least 3 years of experience with FDA, ISO 13485, and EU MDR design-control requirements.
• Demonstrated knowledge and practical application of ISO 14971 and IEC 62366 requirements.
• Strong statistical data-analysis skills using Minitab.
• Competence with Microsoft Office applications.

Responsibilities

• Work on cross-functional teams to develop, apply, revise, and maintain quality and regulatory standards for designing and processing materials and products into partially finished or finished medical devices.
• Implement methods and procedures to inspect, test, and evaluate the precision and accuracy of products and production equipment.
• Diagnose and resolve manufacturing and quality-system issues.
• Participate in design reviews and pre-validation assessments to support safe and environmentally sound start-up of new processes.
• Generate and maintain product-development risk-management files, including plans and reports, hazard analyses, FMEAs, design trace matrices, and post-market surveillance plans.
• Provide guidance and prepare reports involving statistical analysis, including sample-size requirements, process capability, regression, tolerance interval analysis, and ANOVA.
• Support product and process development optimization by guiding design of experiments for process parameters and analyzing data.
• Write process-validation protocols, analyze data, and prepare and release process-validation reports.
• Communicate with customers as needed regarding design and development responsibilities, quality issues, and supplier-initiated change requests.
• Support external customer and notified-body audits, as applicable.
• Investigate and manage customer field complaints, supplier corrective action requests (SCARs), and internal corrective and preventive actions (CAPAs), as needed.
• Represent Quality Assurance in non-conformance report dispositions and participate in monthly Oversight Review Boards, as needed.
• Provide training on quality-system procedures and industry regulations and best practices.
• Interface with customers and suppliers regarding quality issues and project requirements.
• Follow safety and production standard operating procedures.
• Ensure personal and company compliance with applicable federal, state, local, and company health, safety, and environmental regulations, policies, and procedures.
• Be responsible for purchasing or designing equipment that meets company health, safety, and environmental standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior