Lead Quality Engineer

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

Job Description

We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality engineering activities within a regulated manufacturing environment. The role will lead quality improvement initiatives, validation activities, risk management, CAPA, nonconformance investigations, supplier quality, and new product development while ensuring compliance with applicable FDA, ISO, GMP, and quality system requirements.

Job Description

We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality engineering activities within a regulated manufacturing environment. The role will lead quality improvement initiatives, validation activities, risk management, CAPA, nonconformance investigations, supplier quality, and new product development while ensuring compliance with applicable FDA, ISO, GMP, and quality system requirements.

Responsibilities

• Lead and provide technical direction for Quality Engineering activities across manufacturing and product development.
• Develop, implement, and maintain quality plans, procedures and engineering controls.
• Lead CAPA, nonconformance, deviation, complaint and root cause investigations.
• Support and lead process validation, equipment qualification and test method validation activities.
• Develop and review PFMEA, DFMEA, risk assessments, control plans and inspection plans.
• Support Design Controls, Verification & Validation (V&V), NPI and Design Transfer activities.
• Lead continuous improvement initiatives using Lean, Six Sigma, SPC, DOE and statistical analysis.
• Monitor process capability, quality metrics, defects and trends to identify improvement opportunities.
• Provide quality engineering support for manufacturing process development and sustaining engineering.
• Lead supplier quality activities, including supplier qualification, audits, corrective actions and performance improvement.
• Ensure compliance with FDA regulations, ISO 13485, GMP and applicable quality standards.
• Support internal, supplier and regulatory audits.
• Review and approve quality and validation documentation.
• Collaborate with R&D, Manufacturing, Operations, Regulatory, Supply Chain and Supplier Quality teams.
• Provide technical guidance, mentoring and training to junior Quality Engineers.
• Lead moderately to highly complex quality projects and ensure delivery within established timelines.

Requirements:

• Bachelor's degree in engineering, Quality, Manufacturing, Mechanical, Biomedical, Industrial Engineering or related field.
• 7+ years of Quality Engineering experience, preferably in medical device, pharmaceutical, biotech or other regulated manufacturing environments.
• Strong knowledge of Quality Management Systems and regulatory requirements.
• Experience with CAPA, nonconformance, root cause analysis, risk management and process validation.
• Hands‑on experience with PFMEA/DFMEA, SPC, MSA, Gage R&R and Control Plans.
• Strong analytical, problem‑solving, project management and communication skills.
• Experience leading cross‑functional teams and quality improvement projects.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with FDA 21 CFR Part 820 and ISO 13485.
• Experience with Minitab, JMP or other statistical software.
• Experience with Design Controls and medical device product development.
• Experience with supplier quality and manufacturing transfers.
• Master's degree in Engineering or Quality‑related discipline preferred.