Supplier Quality Engineer III

Verathon•Bothell, WA

1d•Onsite

About The Position

The Supplier Quality Engineer is responsible for primary Quality contact with suppliers and for assessment of new suppliers. Monitors the performance of existing suppliers, requalifying suppliers, and the effectiveness of the Quality System in managing the supplier base. Provides routine daily support for Supplier Quality activities through attendance and support of the Material Review Board team and related activities. Supports supplier selection, development and audit process through monitoring, review and quality analysis of the supplier selection process.

Requirements

Bachelor’s degree in Electrical or Mechanical Engineering or related discipline required
5+ years of work experience demonstrating a strong level of expertise in supplier quality
3+ years of experience in manufacturing
Excellent analytical, technical writing and verbal communication skills
Knowledge of FDA (820.50 & 60) and ISO (13485) requirements
Experience with PPAP (Production Part Approval Process) requirements, tools, processes, and deployment
Knowledge of quality improvement tools, including statistical methods.
Ability to lift to 35 pounds.

Nice To Haves

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

Responsibilities

Develop supplier audit processes and procedures
Manage 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 expertise to suppliers (e.g., statistical process control support, capability studies)
Establish policies and procedures that govern development of inspection characteristics to be followed in incoming quality inspection
Monitor inspection effectiveness.
Resolve supplier quality issues at incoming inspection and on the production line
Provide team leadership 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
Provides technical expertise in development and maintenance of incoming inspection training packages
Provides 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
Provides training and direction of supplier quality technicians and performs supplier quality analysis
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