quality engineer, staff

Confluent Medical Technologies INC; Austin (TX); On-site; USD 95,000 - 125,000; Full time

Job summary

Confluent Medical Technologies INC seeks a Quality Assurance Engineer in Austin, TX to ensure compliance with FDA, ISO 13485, and EU MDR. You will lead risk management activities, participate in design reviews, and support transfer to manufacturing while maintaining QA systems.

You will develop and execute validation and verification plans, analyze data with Minitab, and interact with customers and suppliers to resolve quality issues.

Qualifications

• BS in a related engineering discipline and 5 years in medical device quality.
• MS in engineering and 3 years in medical device quality.
• 3+ years in medical device product development and FDA/ISO knowledge.

Responsibilities

• Develop and maintain quality systems and procedures to ensure compliance with FDA, ISO 13485, and EU MDR.
• Lead risk management activities including FMEAs and risk control processes.
• Support design reviews, process validation plans and verification testing.

Skills

Quality Assurance

Statistical analysis

Regulatory compliance

Design reviews

Education

BS in engineering

MS in engineering

Tools

Minitab

Excel

Document control systems

Job description

Job Description:Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing. Our primary capabilities include: Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.We’re looking for a Quality Assurance Engineer to join our Austin, TX Team!As a uniquely qualified candidate, you will:Ensure that compliance to customer, risk management, quality and design control requirements is demonstrated in design and development projects. Help to ensure successful transfer of the design to manufacturing.Work on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills. Participate in decisions on scope of work, selection of materials/equipment/test methodology and length of tasks. Participate in decisions on design changes to meet revised specifications. Provide and develop solutions to problems of limited to moderate scope.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products.Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.Diagnose and resolve manufacturing and quality system issues.Participate in performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents.Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.Support Product/ Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.Write Process Validation Protocols, Analyze data and write and release Process Validation Reports.Communicate with Customer as needed on Design and Development Responsibilities, Quality Issues and or Supplier Initiated Change Requests.Support Hosting of External Customer and or Notified Body Audits as applicable.Investigate and manage customer field complaints, SCAR’s and internal CAPA’s as needed.Represent Quality Assurance for Non-Conformance Report dispositions, and participate in monthly Oversight Review Boards as needed.Provide training on quality system procedures and industry regulations/best practices.Interface with customers and suppliers as needed for quality issues and project requirements.Follows all safety and production standard operating procedures.Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.EDUCATION and/or EXPERIENCE:BS in a related engineering discipline; and 5 years of related experience working in Quality in a medical device environment or equivalent combination of education and experienceMS in a related engineering discipline and 3 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience3+ years experience in Medical Device Product Development3+ years experience with FDA, ISO 13485 and EU MDR Design Control requirementsDemonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirementsStrong statistical data analysis skills using MinitabCompetent in Microsoft Office applications