Med Device Quality Engineer – Risk & Process Improvement

Permobil; Pasco (WA); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision

HSA matching

401(k) employer match

Generous PTO

Employer-paid LTD/STD/Life

Job summary

Permobil is seeking a Quality Engineer in Pasco, WA to drive quality initiatives across raw materials, components, and finished products. This role focuses on risk management, regulatory compliance, data analysis, and cross-functional collaboration to ensure product safety and performance.

The candidate will work with ISO 13485, 21 CFR 820 guidance, and Lean/Six Sigma methods to lead improvements on the production line and supplier quality, with direct impact on patient mobility solutions.

Qualifications

• Bachelor's degree in engineering and 2 years related experience.
• Familiarity with medical device regulations (21 CFR 820) and ISO 13485 preferred.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Experience utilizing Root Cause Analysis techniques (8D, 5-Why, Ishikawa, FTA).
• Experience with Lean/Six Sigma in manufacturing environments preferred.

Responsibilities

• Investigating non-conforming material and determining disposition; establishing acceptance criteria and inspection methods.
• Applying ISO 14971 and government risk management requirements; supporting risk management activities.
• Tracking data on product quality; leading Lean/Six Sigma activities; presenting reports to managers.
• Educating on regulations and standards; supporting audits.
• Participating in workshops and staying updated on company products and technology.
• Monitoring production line quality and coordinating improvements with operations.
• Other duties as assigned.

Skills

Microsoft Office

Root Cause Analysis

LEAN / Six Sigma

Communication

Statistical methods

Education

Bachelor's degree in engineering

Tools

Excel

PowerPoint

FMEA

Job description

Permobil is seeking a Quality Engineer in Pasco, WA to drive quality initiatives across raw materials, components, and finished products. This role focuses on risk management, regulatory compliance, data analysis, and cross-functional collaboration to ensure product safety and performance.

The candidate will work with ISO 13485, 21 CFR 820 guidance, and Lean/Six Sigma methods to lead improvements on the production line and supplier quality, with direct impact on patient mobility solutions.