Quality Engineer: Regulatory Compliance & Improvement

Industrial Scientific Corporation; Everett (WA); On-site; USD 81,000 - 136,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Fortive Corporation, through its Fluke Health Solutions division, seeks a Quality Engineer to ensure compliance with FDA/QSR, GMP, ISO 9001/13485/17025 and related standards. You will drive CAPA, document control, audits, and cross-functional improvements on the Everett, WA site.

Responsibilities include risk analyses, design transfer support, supplier actions, and data-driven quality improvement using Six Sigma and Lean methods.

Qualifications

• BA/BS in Engineering or physical sciences preferred; equivalent experience accepted.
• 3-5 years of related experience required.
• Knowledge of FDA QMSR, ISO 13485, ISO 9001 and/or ISO 17025.
• Experience with quality engineering concepts and validation principles.
• Ability to collaborate across functions and analyze data.

Responsibilities

• Ensure document control for medical activities.
• Handle CAPA, non-conformances, complaints and MRB activities.
• Coordinate QA/Reg Affairs with cross-functional teams.
• Participate in audits and supplier corrective actions (SCAR).
• Support NPIs and design transfer for manufacturing processes.
• Perform data collection and periodic quality reviews.
• Lead root cause analyses and risk assessments.
• Apply Six Sigma/Lean methods to improve quality.

Skills

Quality engineering

Root cause analysis

Cross-functional collab

Six Sigma

Presentation skills

MS Word/Excel

Regulatory awareness

Education

BA/BS in Engineering or physical sciences

Tools

MS Excel

PowerPoint

Job description

Fortive Corporation, through its Fluke Health Solutions division, seeks a Quality Engineer to ensure compliance with FDA/QSR, GMP, ISO 9001/13485/17025 and related standards. You will drive CAPA, document control, audits, and cross-functional improvements on the Everett, WA site.

Responsibilities include risk analyses, design transfer support, supplier actions, and data-driven quality improvement using Six Sigma and Lean methods.