Supplier Quality Engineer II
Verathon, Inc.
- Bothell, WA
- $80,195-106,103 per year
- Permanent
- Full-time
- Execute supplier audits and close audit findings
- Support the performance of onsite supplier quality audits in support of cGMP compliance procedures
- Provide support for onsite supplier selection surveys and capability studies, in support of corporate supplier development goals
- Coordinate with internal commodity teams to establish development plans
- Provide quality systems assistance to suppliers (e.g., statistical process control support, capability studies)
- Monitor inspection effectiveness
- Resolve supplier quality issues at incoming inspection and on the production line
- Provide team support for projects/investigations relating to supplier quality issues
- Manage supplier corrective action request (SCAR) initiation and follow-up with assigned supplier base processes
- Facilitate resolution of internal/external material quality issues by participating in root cause analysis and by working with suppliers to monitor corrective action
- Support internal corrective action and material validation teams, as required
- Supports quality systems training to production and incoming quality inspectors, as required
- Provides information to suppliers and internal organizations through written and oral presentations and reports
- Ensures compliance and audit readiness of assigned supplier quality files
- Maintains and administers the supplier quality related portion of ASL, maintaining supplier status
- Reports on supplier performance via routine, defined metrics
- May lead or assist in supplier development/improvement projects Qualifications:
- Bachelor’s degree in Electrical or Mechanical Engineering or related discipline required; Master’s or graduate level degree preferred
- 2-3 years of work experience demonstrating a strong level of expertise in supplier quality
- 2-3 years of experience in manufacturing
- Excellent analytical, technical writing and verbal communication skills
- Knowledge of FDA (820.50 & 60) and ISO (13485) requirements
- Certified Quality Auditor (CQA, RAB) certificate or Certified Quality Engineer (CQE) certificate preferred
- Experience with PPAP (Production Part Approval Process) requirements, tools, processes, and deployment preferred
- Knowledge of quality improvement tools, including statistical methods.
- Ability to lift to 35 pounds.
- Up to 40% domestic and international travel is required