Senior Quality Leader for Medical Devices & Regulatory QA

Katalyst CRO; City of Albany (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality engineering, regulatory compliance, and continuous improvement across the product lifecycle. This role focuses on driving QMS, risk management, CAPA, and process improvements in regulated environments.

The ideal candidate brings extensive experience in medical, pharmaceutical, biotech, or advanced manufacturing settings and will mentor engineers while coordinating with cross-functional teams to ensure regulatory

Qualifications

• Bachelor's degree in a related technical discipline.
• 10+ years of Quality Engineering experience in a regulated industry.
• Strong knowledge of QMS, quality engineering principles, and regulatory compliance.
• Experience with ISO 13485 and/or ISO 9001 Quality Management Systems.
• Knowledge of FDA 21 CFR Part 820/QMSR and applicable global quality regulations.
• Hands-on experience with CAPA, Non-Conformance (NC), Complaint Handling, Risk Management, FMEA, and Root Cause Analysis.
• Experience supporting design transfer, process validation, manufacturing support, and New Product Introduction (NPI).
• Proficiency in statistical methods including SPC, MSA, DOE, capability analysis, and data-driven decision making.
• Experience leading internal, supplier, customer, and regulatory audits.
• Excellent leadership, communication, and stakeholder management skills.

Responsibilities

• Provide technical leadership for quality engineering activities across product development, manufacturing, and sustaining engineering.
• Lead Quality planning for New Product Introduction (NPI), design transfer, process validation, and manufacturing readiness.
• Develop, implement, and continuously improve Quality Management System (QMS) processes in compliance with regulatory and industry standards.
• Lead investigations for non-conformances, customer complaints, and quality issues using structured root cause analysis and drive effective CAPA implementation.
• Develop and maintain risk management documentation, including Design and Process FMEAs, hazard analysis, and risk mitigation plans.
• Support qualification and validation activities, including IQ/OQ/PQ, process validation, and equipment qualification.
• Partner with Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and Operations to resolve complex quality issues.
• Analyze quality metrics and statistical data to identify trends and implement data-driven process improvements.
• Lead supplier quality initiatives, supplier qualification, audits, and corrective action programs.
• Ensure compliance with FDA regulations, ISO standards, and applicable global regulatory requirements.
• Support internal, customer, and regulatory audits and ensure timely closure of audit observations.
• Mentor and coach Quality Engineers while serving as a technical resource for quality-related decisions.
• Drive Lean, Six Sigma, and continuous improvement initiatives to improve product quality, reduce defects, and increase operational efficiency.

Skills

QMS knowledge

CAPA

Root Cause Analysis

Process Validation

NPI

Design Transfer

Statistical Methods

Audit Leadership

Lean Six Sigma

Regulatory Compliance

Education

Mechanical Eng

Biomedical Eng

Industrial Eng

Manufacturing Eng

Quality Eng

Tools

SAP

Minitab

TrackWise

SmartSolve

Job description

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality engineering, regulatory compliance, and continuous improvement across the product lifecycle. This role focuses on driving QMS, risk management, CAPA, and process improvements in regulated environments.

The ideal candidate brings extensive experience in medical, pharmaceutical, biotech, or advanced manufacturing settings and will mentor engineers while coordinating with cross-functional teams to ensure regulatory