quality engineer, staff

Confluent Medical Technologies•Austin, TX

About The Position

Confluent Medical Technologies is seeking a Quality Assurance Engineer to join its Austin, Texas team. The role supports medical-device design and development projects by ensuring compliance with customer, risk-management, quality, and design-control requirements, and by helping transfer designs successfully into manufacturing. The engineer works on moderately to complex projects, applies industry regulations and best practices, contributes to decisions about project scope, materials, equipment, test methods, and task duration, and helps address design changes and other problems. As part of cross-functional teams, the engineer develops, applies, revises, and maintains quality and regulatory standards for materials and products used in partially or fully finished medical devices. The role supports inspection and testing methods, manufacturing and quality-system issue resolution, design reviews, process development and validation, risk-management documentation, customer and supplier quality matters, audits, complaints, and corrective and preventive actions. It also provides statistical analysis and quality-system training while following applicable safety, production, and environmental requirements.

Requirements

Bachelor's degree in a related engineering discipline and five years of related experience working in Quality in a medical-device environment, or an equivalent combination of education and experience.
Alternatively, a master's degree in a related engineering discipline and three years of related experience working in Quality in a medical-device environment, or an equivalent combination of education and experience.
At least three years of experience in medical-device product development.
At least three 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

Ensure customer, risk-management, quality, and design-control requirements are demonstrated in design and development projects and support transfer of designs to manufacturing.
As part of a cross-functional team, develop, apply, revise, and maintain quality and regulatory standards for designing and processing materials and products into partially or finished medical devices.
Implement methods and procedures for inspecting, testing, and evaluating 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 reports on 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 about design and development responsibilities, quality issues, and supplier-initiated change requests as needed.
Support hosting 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 as needed.
Follow safety and production standard operating procedures.
Ensure personal and company compliance with applicable health, safety, and environmental regulations, policies, and procedures.
Ensure equipment purchases or designs meet company health, safety, and environmental standards.