Supplier Quality Engineer – Biotechnology – Austin

Summary: The Supplier Quality Engineer will be responsible for

  • Interacting with suppliers to address quality excursions observed at any of the Luminex sites.
  • Interfacing with Operations, Engineering, and Sourcing for supplier performance monitoring and selection
  • Driving continuous improvement plans with suppliers.

Key Responsibilities and Duties:

  • Act as the Quality liaison between the suppliers and the manufacturing sites.
  • Lead supplier audits and audit reporting.
  • Monitor and Measure supplier performance through measurement of production line statistics, Field data, company inspections, and audits.
  • Leading or assisting in the investigation and resolution of problems initiated through non-conformances, corrective action, or customer complaints linked to suppliers.
  • Establish and report supplier quality metrics as required.
  • Assists in supplier selection & qualification process for new products and sourcing activities.
  • Participate in or lead the coordination of supplier conference meetings, site visits, and audits.
  • Establish meetings with low scoring suppliers to communicate quality issues, discuss root cause and drive corrective actions.
  • Work with critical suppliers to improve product quality levels through the development of processes and controls at the supplier (e.g. control plans, test methods, test plans, and test fixtures, etc.)

Education and Experience:

  • Bachelors of Science degree required, in a life science/engineering discipline
  • Experience in a Good Manufacturing Practices (GMP) environment required, preferably in a medical device industry.
  • Working knowledge of current industry quality practices, such as QSRs, ISO-13485.
  • Minimum 5 years of quality, supplier quality, or manufacturing experience in a relevant

Training, Skills and Certifications/Licenses:

  • Certification in a quality discipline preferred, such as ASQ certified Quality Engineer (CQE), Quality Auditor (CQA), etc.
  • Proficient in Microsoft Word, Excel, Access and PowerPoint programs.
  • Strong statistical and data analysis skills and problem-solving techniques; SPC, DOE, 8D

Work Conditions:

  • Austin, TX
  • 15-25% Travel may be required; limited international travel
  • Possible exposure to mechanical, biologic and chemical hazards
  • Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting at least 10 lbs

Interested candidates should visit the Luminex Career site for additional information on an available opportunity – Supplier Quality Engineer #437 –