Senior Quality Engineering Lead – Regulatory & Process Excellence

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

Job summary

Creative Solutions Services, LLC is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development. The role focuses on compliance, product quality, and continuous improvement, partnering with cross-functional teams to drive excellence.

The ideal candidate will oversee quality systems, risk management, validation, supplier quality, and regulatory compliance, while mentoring engineers and supporting audits and inspections.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 8+ years of Quality Engineering in a regulated environment.
• FDA/ISO13485/cGMP knowledge required.
• Experience with Design Controls, CAPA, and risk management.

Responsibilities

• Lead quality engineering activities across product development and manufacturing.
• Develop and implement quality strategies compliant with FDA, ISO 13485, ISO 9001.
• Drive CAPA through structured problem-solving approaches (8D, 5 Whys, Fishbone).
• Lead risk management activities including DFMEA, PFMEA, risk assessments, mitigation plans.
• Review and approve ECOs, design documentation, validation protocols, and quality records.
• Support Design Controls including V&V, Design Reviews, and DHF.
• Analyze quality metrics and drive continuous improvement with Lean Six Sigma and statistics.
• Lead IQ/OQ/PQ and process capability studies; support audits and inspections.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Quality Engineering

Regulatory Compliance

Root Cause Analysis

CAPA

Process Validation

Risk Management

Lean Six Sigma

Statistical Analysis

Audits

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

Minitab

Job description

Creative Solutions Services, LLC is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development. The role focuses on compliance, product quality, and continuous improvement, partnering with cross-functional teams to drive excellence.

The ideal candidate will oversee quality systems, risk management, validation, supplier quality, and regulatory compliance, while mentoring engineers and supporting audits and inspections.