Principal Quality Engineer – Medical Devices & Compliance

Katalyst CRO; Spokane (WA); On-site; USD 130,000 - 210,000; Full time

Job summary

Katalyst CRO in Spokane, WA seeks a Principal Quality Engineer to lead quality initiatives across manufacturing and development, ensuring regulatory compliance and product quality. The role drives CAPA, risk management, validation, and supplier quality while partnering with R&D, Regulatory, and Operations.

The ideal candidate brings extensive experience in cGMP, ISO standards, and quality systems, with a track record of delivering continuous improvement through data-driven methods and Lean Six

Qualifications

• Bachelor's degree in Engineering ( Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related ).
• 8+ years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, and change management.
• Hands-on experience with IQ/OQ/PQ, statistical analysis, SPC, MSA, and capability studies.
• Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
• Experience leading cross-functional projects and mentoring engineering teams.
• Strong written, verbal, and presentation skills.

Responsibilities

• Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
• Drive root cause investigations and CAPA using structured problem-solving methodologies.
• Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Review and approve ECOs, design documentation, validation protocols, and quality records.
• Support design control activities including Design Verification & Validation (V&V), Design Reviews, and DHF.
• Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
• Lead process validation activities including IQ, OQ, PQ, and process capability studies.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
• Provide technical leadership during internal, customer, and regulatory audits.
• Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
• Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
• Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Skills

FDA Regulations

ISO 13485

cGMP

CAPA

Design Controls

Risk Management

Process Validation

Lean Six Sigma

8D Problem Solving

Auditing

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

SPC

MS Excel

Job description

Katalyst CRO in Spokane, WA seeks a Principal Quality Engineer to lead quality initiatives across manufacturing and development, ensuring regulatory compliance and product quality. The role drives CAPA, risk management, validation, and supplier quality while partnering with R&D, Regulatory, and Operations.

The ideal candidate brings extensive experience in cGMP, ISO standards, and quality systems, with a track record of delivering continuous improvement through data-driven methods and Lean Six