Senior Quality Engineer

Location: Everett, WA

As a Senior Quality Engineer at Fluke, you will play a critical role in ensuring the quality, reliability, and safety of Fluke products across the entire product lifecycle. 

This position demands strong analytical capability, technical depth in electronics and mechanical systems, disciplined problem solving, and the ability to influence teams without authority. 

You will drive robust quality planning, verification and validation rigor, risk mitigation, and continual improvement initiatives. You will ensure that Fluke products meet customer expectations, comply with regulatory and industry standards, and deliver world‑class performance in the field.

The ideal candidate will have hands on experience in representing Product Quality in Engineering Design Reviews, Product Part Approval Process (PPAP) / Advanced Product Quality Planning (APQP) (or equivalent), problem solving, and a 3rd party ISO 9001:2015 Lead Auditor credentials.

Key Responsibilities:

Design & Development Quality

• Lead development, review, and execution of product lifecycle quality plans from concept through launch.
• Own and drive Design for Quality (DfQ), DFMEA, design control deliverables, ensuring traceability from requirements to verification / validation.
• Champion risk management throughout the lifecycle owning control plans and maintaining risk files.
• Define acceptance criteria, test strategies, measurement system analyses (MSA/GR&R), and Critical‑to‑Quality (CtQ) parameters.
• Partner with Design Engineering, Product Management, and Operations on design specifications, manufacturability, reliability, and risk.
• Plan and execute APQP (or equivalent) including PFMEA, control plans, PPAP, and process capability analysis / rolled throughput yield (RTY), and production readiness assessments.
• Validate production test systems, calibration methods, and in-process inspection strategies.
• Ensure smooth transition from development to production through cross‑functional reviews and readiness gates.
• Track and own launch quality metrics (DPPM, escapes, warranty early life failures).
• Monitor product health (returns, complaints, yields, warranty, reliability, etc.) and own problem solving to drive continual improvement.
• Identify, measure, monitor, and improve product rework and scrap that contributes to Cost of Poor Quality (CoPQ).
• Lead root‑cause investigations using 8D, 5‑Whys, Ishikawa, and statistical methods.
• Lead stop ship, containment, investigations, communications and other quality-related activities.
• Optimize in-process and end of line inspection and testing strategies and reduce variation.

Sustaining Quality

• Support change control evaluations (ECOs, process changes, component changes) to ensure continued product quality.
• Collaborate with Service and Customer Support on customer issues, containment, corrective actions and communication.
• Lead cross‑functional quality reviews and drive consensus on quality‑critical decisions.
• Communicate risks, issues, and performance trends to leadership with clarity and data‑driven insights.
• Serve as lead auditor for ISO 9001:2015 in planning, executing, and reporting internal audits while supporting external audits.
• Ensure quality procedures, work instructions and records meet QMS requirements.
• Support supplier and customer audits, including verification of effectiveness of closure on nonconformities.
• Promote a culture of quality, data integrity, and continual improvement leveraging the Fortive Business System (FBS). 

Required Qualifications

• Bachelor’s degree in Electrical, Manufacturing, Systems, Mechanical, or related engineering discipline.
• 5-8+ years of Quality Engineering experience across hardware, electromechanical, or embedded system products.
• Strong knowledge of V&V methodologies, statistical tools, and quality engineering principles.
• Knowledge of ISO 9001/ 13485, ISO/IEC 17025, AS9100D, or similar standards.
• Experience with DFMEA, PFMEA, MSA, GR&R, control plans, and structured problem solving.
• Experience in Lean, Kaizen, or Six Sigma (Green Belt or higher).
• Experience with PCBA processes, electronics manufacturing, or test system development.
• Familiarity with PLM, ERP, MES, or digital quality systems.
• Familiarity with Reliability Engineering concepts and methods (Weibull analysis, FRACAS)
• Hands‑on experience with failure analysis and reliability concepts.
• Proficiency with data analysis tools (Minitab, Power BI, or similar).
• ASQ Certified Quality Engineer or equivalent.
• Ability to influence without authority and deliver results in a fast‑paced environment.
• High sense of ownership, urgency, and continuous improvement mindset.
• Internal auditor or lead auditor certification (preferred)