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About the Role
Confluent Medical Technologies is seeking a Quality Assurance Engineer to join their Austin, TX team. This role is crucial for ensuring compliance with customer, risk management, quality, and design control requirements throughout design and development projects, and facilitating the successful transfer of designs to manufacturing.
Responsibilities
- Develop, apply, revise, and maintain quality and regulatory standards for medical device product design and processing.
- Implement methods for inspecting, testing, and evaluating product and equipment precision and accuracy.
- Diagnose and resolve manufacturing and quality system issues.
- Participate in design reviews and pre-validation assessments for new process start-ups.
- Generate and maintain risk management files, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, and Post Market Surveillance plans.
- Provide guidance and generate reports on statistical analysis topics such as sample size requirements, process capability, regression analysis, tolerance interval analysis, and ANOVA.
- Support Product/Process Development Engineering in optimization activities by guiding Design of Experiments and analyzing data.
- Write Process Validation Protocols, analyze data, and write and release Process Validation Reports.
- Communicate with customers regarding design and development responsibilities, quality issues, and supplier-initiated change requests.
- Support external customer and notified body audits.
- Investigate and manage customer field complaints, SCARs, and internal CAPAs.
- Represent Quality Assurance for Non-Conformance Report dispositions and participate in Oversight Review Boards.
- Provide training on quality system procedures and industry regulations/best practices.
- Interface with customers and suppliers on quality issues and project requirements.
- Follow all safety and production standard operating procedures.
- Ensure compliance with all company and regulatory Health, Safety, and Environmental regulations.
- Oversee the purchase or design of equipment that meets health, safety, and environmental standards.
Requirements
- Ensure compliance to customer, risk management, quality, and design control requirements in design and development projects.
- Facilitate successful transfer of design to manufacturing.
- Analyze situations and data requiring knowledge of industry regulations and best practices.
- Participate in decisions regarding scope of work, material/equipment selection, test methodology, and task duration.
- Participate in decisions on design changes to meet revised specifications.
- Provide and develop solutions to problems of limited to moderate scope.
- Demonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirements.
Skills
- Statistical data analysis skills using Minitab
- Competent in Microsoft Office applications
Location
- Austin, TX
Work Type
- Full-time
Experience Level
- 5 years of related experience working in Quality in a medical device environment (with BS)
- 3 years of related experience working in Quality in a medical device environment (with MS)
- 3+ years experience in Medical Device Product Development
- 3+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements
Education Level
- BS in a related engineering discipline
- MS in a related engineering discipline
About the Company
- Confluent Medical Technologies is dedicated to working collaboratively with customers, taking projects from rapid prototype into high volume production.
- Possesses unparalleled technical expertise, proven experience, and partnerships with clients to deliver world-class medical devices through innovative material science, engineering, and manufacturing.
- Primary capabilities include: Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.
- A leader in the medical technology space, driven by a passion to create products that clients have envisioned.