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Supplier Quality Engineer

Job Summary:

Manage supplier quality activities and drive quality and process improvement. Assess, monitor, and ensure the continued adequacy and effectiveness of Nanostring’s Supplier Quality System. Support supplier selection, supplier process validation/controls, supplier auditing, supplier corrective actions and supplier development. This position interacts with Procurement, Manufacturing, Sustaining Engineering, R&D and Quality to ensure quality of incoming materials.

Essential Duties:

  • Drive failure analysis and supplier corrective action requests (SCAR)
  • Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures
  • Approve supplier manufacturing/test/inspection plans and procedures
  • Perform periodic supplier audits and risk assessments
  • Ensure the proper validation of supplier processes and test methods and the product/process change management process
  • Work closely with critical suppliers to sustain and improve component quality
  • Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records
  • Support new supplier development and commodity team strategies
  • Participate in design reviews with the development teams
  • Maintain supplier key performance indicators (KPIs) and drive continuous improvement; support any score carding activities
  • Correlate and standardize test and inspection processes as required
  • Maintain 100% compliance to Nanostring processes, procedures and specifications
  • May participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems
  • Other related duties as assigned

Requirements:

  • Bachelor's degree in an engineering, Life Science or equivalent combination of education and directly relevant experience
  • A minimum of 5 years of experience in a GMP and/or FDA regulated industry is required
  • Experience in the medical device and/or pharmaceutical industry is preferred
  • Operations supplier quality experience is preferred
  • Demonstrated understanding of statistical control and quality management principles
  • Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
  • ISO 13485 Auditor trained or experience with supplier auditing
  • Strong communication, teamwork, and problem-solving skills are required
  • Strong root cause analysis skills are required
  • Six Sigma, Lean, or ASQ Certification and/or trainings are preferred
  • Up to 25% travel may be required

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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