Supplier Quality Engineer II

Verathon•Bothell, WA

About The Position

Verathon is a global medical device company that develops Airway Management and Urology solutions. The Supplier Quality Engineer serves as the primary Quality contact for suppliers and assesses new suppliers. The role monitors existing supplier performance, requalifies suppliers, and evaluates the effectiveness of the Quality System in managing the supplier base. It also provides routine support for Supplier Quality activities, including Material Review Board participation, and supports supplier selection, development, and audits through monitoring, review, and quality analysis.

Requirements

  • Bachelor’s degree in Electrical or Mechanical Engineering, or a related discipline.
  • 2–3 years of work experience demonstrating a strong level of expertise in supplier quality.
  • 2–3 years of manufacturing experience.
  • Excellent analytical, technical writing, and verbal communication skills.
  • Knowledge of FDA requirements (820.50 and 820.60) and ISO 13485 requirements.

Nice To Haves

  • Master’s or graduate-level degree.
  • Certified Quality Auditor (CQA, RAB) certificate or Certified Quality Engineer (CQE) certificate.

Responsibilities

  • Execute supplier audits and close audit findings.
  • Support onsite supplier quality audits to help ensure compliance with cGMP procedures.
  • Support onsite supplier selection surveys and capability studies in support of supplier development goals.
  • Coordinate with internal commodity teams to establish supplier development plans.
  • Provide suppliers with quality systems assistance, such as statistical process control support and capability studies.
  • Monitor inspection effectiveness.
  • Resolve supplier quality issues at incoming inspection and on the production line.
  • Support projects and investigations relating to supplier quality issues.
  • Manage supplier corrective action request (SCAR) initiation and follow-up with assigned suppliers.
  • Facilitate resolution of internal and external material quality issues by participating in root cause analysis and working with suppliers to monitor corrective actions.
  • Support internal corrective action and material validation teams as required.
  • Support quality systems training for production and incoming quality inspectors as required.
  • Provide information to suppliers and internal organizations through written and oral presentations and reports.
  • Ensure compliance and audit readiness of assigned supplier quality files.
  • Maintain and administer the supplier quality portion of the Approved Supplier List (ASL), including supplier status.
  • Report supplier performance using routine, defined metrics.
  • Lead or assist with supplier development and improvement projects.

Benefits

  • Competitive benefits package including medical, dental, and vision coverage.
  • Basic life insurance.
  • Auto allowance.
  • 401(k) matching plan.
  • Annual bonus plan eligibility for full-time employees who are not on a commission plan, based on company and individual performance.
  • Professional development programs, internal promotions, certification courses, and tuition reimbursement.
  • Team appreciation events, team-building activities, and celebrations.
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