Principal Quality Engineer - Regulatory Quality

Katalyst-Healthcares-; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Katalyst-Healthcares- in Cambridge, MA seeks a Principal Quality Engineer to lead quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance across manufacturing and product development. The role partners with cross-functional teams to drive continuous improvement and operational excellence.

You will provide technical leadership during audits, mentor Quality Engineers, and drive standardization of quality practices using Lean Six Sigma and robust statistical

Qualifications

• 8+ years of quality engineering experience in a regulated manufacturing environment.
• Extensive knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, and change management.
• Hands-on experience with IQ/OQ/PQ, statistical analysis, SPC, MSA, and capability studies.
• Strong Lean Manufacturing and Six Sigma expertise with continuous improvement mindset.
• Excellent root cause analysis using 8D, Fishbone, and 5 Whys.

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 regulatory requirements.
• Drive root cause investigations and corrective and preventive actions (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 V&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 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 QSR (21 CFR Part 820) and applicable international standards.

Skills

Quality leadership

Root cause analysis

Lean Six Sigma

CAPA

Risk management

Statistical analysis

Cross-functional leadership

Mentoring

Education

Bachelor's degree in Engineering

Master's degree

Tools

Minitab

Job description

Katalyst-Healthcares- in Cambridge, MA seeks a Principal Quality Engineer to lead quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance across manufacturing and product development. The role partners with cross-functional teams to drive continuous improvement and operational excellence.

You will provide technical leadership during audits, mentor Quality Engineers, and drive standardization of quality practices using Lean Six Sigma and robust statistical