Principal Quality Engineer — Regulated Medical Devices

Creative Solutions Services, LLC; Birmingham (AL); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in Birmingham, AL seeks a Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and continuous improvement. You will drive CAPA, risk management, design controls, and supplier quality, mentor engineers, and partner with regulatory affairs to support FDA inspections and ISO audits.

This role demands deep knowledge of cGMP, ISO 13485, and Lean Six Sigma, with hands-on experience in

Qualifications

• Bachelor's degree in Engineering required; 8+ years in regulated manufacturing quality engineering.
• Strong knowledge of FDA, ISO 13485, ISO 9001, and cGMP.
• Experience with Design Controls, ISO 14971, CAPA, change management.
• Hands-on IQ/OQ/PQ, SPC, MSA, and capability studies.

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 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 CI 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) and international standards.

Skills

Quality Engineering

Regulatory compliance

Root cause analysis

CAPA

Design controls

Lean Six Sigma

Statistical analysis

Cross-functional collaboration

IQ/OQ/PQ

FDA regulations

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

Job description

Creative Solutions Services, LLC in Birmingham, AL seeks a Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and continuous improvement. You will drive CAPA, risk management, design controls, and supplier quality, mentor engineers, and partner with regulatory affairs to support FDA inspections and ISO audits.

This role demands deep knowledge of cGMP, ISO 13485, and Lean Six Sigma, with hands-on experience in