Supplier Quality Engineer -Medical device

Position Title:

Supplier Quality Engineer (PHIAJP)

Bothell Washington USA 98021

11 months

1

40 (8 hrs/day)

Supplier Quality Engineer

• Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company’s quality standards, and contributes to the supplier selection.
• Conducts and reviews DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request).
• Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality.
• Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers.
• Facilitates collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation.
• Focuses that Critical to Quality (CtQ) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process.
• Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval.
• Executes supplier improvement and development initiatives on APQP (Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency.
• Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained.
• Supports in end-to-end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier‑caused, and acts as an independent reviewer for Supplier Corrective Action Requests.

• Minimum required
  
  Education:
  
  Bachelor’s / Master’s Degree in Engineering Science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.
• Minimum required
  
  Experience:
  
  Minimum 8 years of experience with a Bachelor’s in areas such as Quality Engineering, Safety Engineering, Process Engineering, Continuous Improvement Techniques or equivalent.
• Minimum required Certification: N/A
• Preferred Education: Master’s degree in Engineering.
• Preferred Experience: 8 years of experience.
• Preferred Certification: LEAN Six Sigma.

• Supplier Quality Management
• Quality Management Procedures and Methodologies
• Supplier Evaluation Methodologies
• Data Analysis & Interpretation
• DfX Methodology
• Supply Chain Management (SCM)
• Quality Specifications
• CAPA Methodologies
• Statistical Process Control (SPC)
• Measurement Systems Analysis (MSA)
• Process Validation and Verification (PV&V)
• First Article Inspections
• Documentation & Reporting
• Regulatory Requirements
• Continuous Improvement