Principal Quality Engineer - Regulatory Excellence

Katalyst CRO; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development. You will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while collaborating with cross‑functional teams to drive operational excellence.

This role emphasizes hands-on process validation (IQ/OQ/PQ), DFMEA/PFMEA, design controls, audits, and continuous improvement using Lean Six

Qualifications

• 8+ years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
• Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, 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 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 engineering change orders (ECOs), design documentation, validation protocols, and quality records.
• Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (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 Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA

Change management

Design controls

Lean Six Sigma

Audits support

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

Job description

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development. You will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while collaborating with cross‑functional teams to drive operational excellence.

This role emphasizes hands-on process validation (IQ/OQ/PQ), DFMEA/PFMEA, design controls, audits, and continuous improvement using Lean Six