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Quality Engineer, Sr Staff

Company: Confluent Medical Technologies INC
Location: Austin
Posted on: January 12, 2021

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 Engineer, Sr Staff to join our Austin, TX Team!As a uniquely qualified candidate, you will:Work on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participate in decisions on scope of work, selection of equipment 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 team for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished 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.* 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 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 coordinate monthly Oversight Review Board presentation as needed.* Participate on cross-functional teams to develop new products and processes.* Revise and provide training to manufacturing documents and other quality-related topics.* 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 6-8 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 4-6 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience* Strong statistical data analysis using Minitab* Competent in Microsoft Excel* Experience in the medical device industry* Experience with the FDA* ASQ Certified Quality Engineer would be an asset* Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques. Good written and oral English communication skills. Computer literate.COMMENTS: This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.

Keywords: Confluent Medical Technologies INC, Austin , Quality Engineer, Sr Staff, Other , Austin, Texas

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