Senior Product Quality Engineer - Hybrid (24+Mo Contract)

Lancesoft; Bothell (WA); Hybrid; USD 128,943,000 - 169,059,000; Full time

Job summary

Lancesoft in Bothell, WA is seeking a Product Quality Engineer for a hybrid role. You will develop and execute process validation strategies, manage design controls, and ensure regulatory compliance across hardware, software, and systems.

You will lead quality improvement projects, perform root cause analysis, and guide risk management throughout the product lifecycle, while preparing for audits and collaborating with cross‑functional teams.

Qualifications

• Bachelor's or Master's degree in Mechanical/Electronics/Science or equivalent.
• Five+ years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent (or Master's with no experience).
• Six Sigma Green Belt preferred.
• Proficiency in regulatory and quality standards.

Responsibilities

• Create and execute comprehensive process validation strategies using statistical tools.
• Lead design control from inputs to transfer and verification/validation.
• Maintain and update quality documentation for hardware, software, and systems.
• Drive quality improvement projects using PMS data and risk assessments.
• Perform root cause analysis and implement corrective actions (CAPA).
• Guide risk management across product lifecycle to ensure safety and quality.
• Prepare for quality audits and inspections with proper documentation.
• Collaborate with manufacturing and design teams to address quality issues.

Skills

Process validation

Design quality

Data analysis

CAPA

Risk management

Regulatory compliance

Quality improvement

Audit readiness

Education

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent

Six Sigma Green Belt (preferred)

Tools

Quality documentation tools

Design Verification Planning

Design Validation Planning

Job description

Lancesoft in Bothell, WA is seeking a Product Quality Engineer for a hybrid role. You will develop and execute process validation strategies, manage design controls, and ensure regulatory compliance across hardware, software, and systems.

You will lead quality improvement projects, perform root cause analysis, and guide risk management throughout the product lifecycle, while preparing for audits and collaborating with cross‑functional teams.