Quality Engineer, Sr. Staff
Quality Engineer, Senior Staff
Full Time Technical
Austin, TX, US
This company 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.
This company is growing! We’re looking for a Quality Engineer, Senior Staff to join our Austin, TX team.
As an uniquely qualified candidate, you will:
Work on problems and projects of moderate to large 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. Decide on design changes to meet revised specifications. Provides and develops solutions to problems of limited to moderate scope. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower level personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
- Independently performs most assignments with instructions as to the general results expected.
- Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
- May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
- Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
- Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
- Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
Diagnose and resolve troubleshoot manufacturing and quality system issues.
- 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.
- May require conducting internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset.
- 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 10 to 15 years of related experience or equivalent combination of education and experience
- MS in a related engineering discipline and 7 to 11 years of related experience or equivalent combination of education and experience
- PhD in a related engineering discipline and 3-6 years of related or experience or equivalent combination of education and experience
- Competent in statistical data analysis using Minitab
- Competent in various tools within Excel
- Experience in the medical device industry and/or manufacturing a plus
- 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).