Lead Quality Engineer for Regulated Med Devices

Creative Solutions Services, LLC; Spokane (WA); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Lead Quality Engineer to provide technical leadership in a regulated manufacturing environment. The role focuses on quality improvement, CAPA, validation, risk management, supplier quality, and NPD while ensuring FDA, ISO 13485, and GMP compliance.

The candidate will lead cross-functional teams, develop quality plans, perform root cause analyses, and drive continuous improvement using Lean Six Sigma and SPC.

Qualifications

• Bachelor's degree in engineering or related field is required.
• 7+ years of Quality Engineering experience in regulated manufacturing environments.
• Strong knowledge of Quality Management Systems and regulatory requirements.
• Experience with CAPA, nonconformance, root cause analysis, and risk management.
• Hands-on experience with PFMEA/DFMEA, SPC, MSA, Gage R&R, and Control Plans.

Responsibilities

• Lead technical direction for Quality Engineering activities across manufacturing and product development.
• Develop and maintain quality plans, procedures, and engineering controls.
• Lead CAPA, nonconformance, deviation, complaint, and root cause investigations.
• Support process validation, equipment qualification, and test method validation.
• 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 improvements.
• 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 timely delivery.

Skills

Quality Engineering

Regulatory compliance

Leadership

CAPA

Risk management

Statistical analysis

Education

Bachelor's degree in Engineering

Tools

PFMEA/DFMEA

MSA

Gage R&R

Control Plans

Minitab/JMP

Job description

Creative Solutions Services, LLC is seeking an experienced Lead Quality Engineer to provide technical leadership in a regulated manufacturing environment. The role focuses on quality improvement, CAPA, validation, risk management, supplier quality, and NPD while ensuring FDA, ISO 13485, and GMP compliance.

The candidate will lead cross-functional teams, develop quality plans, perform root cause analyses, and drive continuous improvement using Lean Six Sigma and SPC.