Lead Quality Engineer — Regulated Medical Devices

Creative Solutions Services, LLC; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and continuous improvement. You will guide risk management, CAPA, supplier quality, and validation activities while partnering with cross-functional teams to drive excellence.

The role emphasizes Design Controls, V&V, and robust quality systems in a regulated environment, with a focus on mentoring engineers and

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related).
• 8+ years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, change management.
• Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis (SPC/MSA).
• Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis using 8D, Fishbone, 5 Whys, and similar tools.

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 regulatory requirements.
• Drive root cause investigations and CAPA using structured problem solving.
• 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 DV/V, Design Reviews, and DHF.
• Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
• Lead process validation activities including IQ, OQ, PQ, and 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 QSR (21 CFR Part 820) and applicable international standards.

Skills

Quality engineering

Root cause analysis

Lean Six Sigma

Statistics

Regulatory compliance

CAPA

Risk management

Design Controls

Process validation

Audit leadership

Education

Bachelor's degree in Engineering

Master's degree in Engineering or related field

ASQ CQE certification

Tools

Minitab

Job description

Creative Solutions Services, LLC seeks an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and continuous improvement. You will guide risk management, CAPA, supplier quality, and validation activities while partnering with cross-functional teams to drive excellence.

The role emphasizes Design Controls, V&V, and robust quality systems in a regulated environment, with a focus on mentoring engineers and