Quality Engineer - Regulatory & Process Excellence

Fluke Health Solutions; Everett (WA); On-site; USD 81,000 - 136,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Fluke Health Solutions seeks a Quality Engineer to ensure FDA/GMP/QSR and ISO compliance across quality systems. You will lead CAPA, NCRs, and MRB while supporting cross-functional teams in continuous improvement.

With 3–5 years of related experience, you will contribute to risk analysis, FMEA, and product/process validation requirements, utilizing Six Sigma and data-driven decision making.

Qualifications

• BA/BS in Engineering or physical sciences preferred; ASQ certifications accepted.
• 3-5 years of related experience required.
• Knowledge of FDA QMSR, ISO 13485:2016, ISO 9001:2015, and/or ISO 17025:2017.
• Knowledge of quality engineering concepts including process control and validation.
• Experience with Complaint, Nonconformance, CAPA, and MRB processing.
• Proficient in using quality tools such as Flow Charts, Pareto Charts, and Control Charts.
• Strong communication and cross-cultural collaboration skills.

Responsibilities

• Ensure document control for medical activities.
• Handle Complaints, Non-Conformances, CAPA, and MRB activities.
• Collaborate across functions to integrate quality activities into site strategies.
• Participate in project teams to improve site performance.
• Assist development of QMS deliverables including risk analysis and FMEA.

Skills

Quality engineering

Regulatory knowledge

Root cause analysis

Six Sigma

Cross-functional collaboration

Presentation skills

Education

BA/BS in Engineering or physical sciences

Tools

PowerPoint

Excel

Statistical tools (Minitab/SPSS)

Job description

Fluke Health Solutions seeks a Quality Engineer to ensure FDA/GMP/QSR and ISO compliance across quality systems. You will lead CAPA, NCRs, and MRB while supporting cross-functional teams in continuous improvement.

With 3–5 years of related experience, you will contribute to risk analysis, FMEA, and product/process validation requirements, utilizing Six Sigma and data-driven decision making.