Lead Quality Engineer – Regulated Medical Devices

Katalyst CRO; Spokane (WA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

None

Job summary

Katalyst CRO is seeking an experienced Lead Quality Engineer to provide technical leadership for quality activities in a regulated manufacturing environment. You will drive CAPA, risk management, validation, supplier quality and new product development while ensuring FDA, ISO 13485 and GMP compliance.

You will lead cross-functional teams, develop and review quality plans, and mentor junior engineers. This role demands strong analytical and problem-solving skills and a track record of delivering

Qualifications

• Bachelor's degree in engineering or related field required.
• 7+ years of quality engineering experience in regulated environments.
• Strong knowledge of QMS and regulatory requirements (FDA/ISO 13485).
• Experience with CAPA, nonconformance, root-cause analysis and validation.
• Hands-on PFMEA/DFMEA, SPC, MSA, Gage R&R and control plans.

Responsibilities

• Lead quality engineering activities across manufacturing and development.
• Develop, implement, and maintain quality plans, procedures and controls.
• Lead CAPA, nonconformance, deviation, and root cause investigations.
• Support process validation, equipment qualification and test method validation.
• Develop and review PFMEA/DFMEA, risk assessments and control plans.
• Support Design Controls, V&V, NPI and Design Transfer.
• Lead continuous improvement using Lean, Six Sigma, SPC, DOE and statistics.
• Monitor process capability, quality metrics and trends for improvements.
• Lead supplier quality activities including supplier qualification and audits.

Skills

Analytical skills

Problem solving

Project management

Communication skills

Cross-functional leadership

Quality engineering

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or Quality-related discipline preferred

ASQ CQE certification

Lean Six Sigma Green Belt or Black Belt certification

Tools

Minitab

JMP

Job description

Katalyst CRO is seeking an experienced Lead Quality Engineer to provide technical leadership for quality activities in a regulated manufacturing environment. You will drive CAPA, risk management, validation, supplier quality and new product development while ensuring FDA, ISO 13485 and GMP compliance.

You will lead cross-functional teams, develop and review quality plans, and mentor junior engineers. This role demands strong analytical and problem-solving skills and a track record of delivering