Job Description: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 experience
- MS 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 experience
- 3+ years experience in Medical Device Product Development
- 3+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements
- Demonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirements
- Strong statistical data analysis skills using Minitab
- Competent in Microsoft Office applications
