Senior Supplier Quality Engineer — Medical Devices

Verathon, Inc.; Bothell (WA); On-site; USD 111,000 - 151,000; Full time

Job summary

Verathon, Inc. in Bothell, WA, seeks a Supplier Quality Engineer to serve as the primary quality contact for suppliers, drive audit programs, and monitor supplier performance within a cGMP framework.

You will support supplier development, CAPAs, and QA activities across internal teams to ensure robust supplier quality systems. The role requires a BS in Electrical or Mechanical Engineering, 5+ years in supplier quality, 3+ years in manufacturing, and travel up to 40%.

Qualifications

• Bachelor's degree in Electrical or Mechanical Engineering or related discipline.
• 5+ years of supplier quality experience.
• 3+ years of manufacturing experience.
• Knowledge of FDA 820.50/60 and ISO 13485 requirements.

Responsibilities

• Develop supplier audit processes and procedures.
• Lead on-site supplier quality audits for cGMP compliance.
• Support supplier selection surveys and capability studies.
• Coordinate with internal teams to establish development plans.
• Provide quality systems expertise to suppliers (statistical methods, SPC).
• Establish policies for incoming quality inspection characteristics.
• Monitor inspection effectiveness and resolve quality issues at incoming and on the production line.
• Lead projects or investigations related to supplier quality.
• Manage SCAR initiation and follow-up.
• Facilitate resolution of material quality issues with root cause analysis.
• Support internal corrective action and material validation teams.
• Provide training for supplier quality and inspection programs.
• Communicate supplier performance via defined metrics.

Skills

Analytical thinking

Technical writing

Verbal communication

Leadership

Problem solving

Education

Bachelor's degree in Electrical or Mechanical Engineering

Master’s degree preferred

Tools

PPAP (Production Part Approval Process)

Statistical methods

Job description

Verathon, Inc. in Bothell, WA, seeks a Supplier Quality Engineer to serve as the primary quality contact for suppliers, drive audit programs, and monitor supplier performance within a cGMP framework.

You will support supplier development, CAPAs, and QA activities across internal teams to ensure robust supplier quality systems. The role requires a BS in Electrical or Mechanical Engineering, 5+ years in supplier quality, 3+ years in manufacturing, and travel up to 40%.