Quality Engineer III – Medical Devices & Product Launch

Katalyst CRO; Franklin Lakes (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer to support new product development and ongoing maintenance for medical devices. You will apply quality engineering principles to ensure products meet design control and regulatory requirements.

Active involvement in audits, risk management, and process validation will be required. The role emphasizes collaboration with cross-functional teams, adherence to quality standards, and contribution to continuous improvement initiatives to support product quality and

Qualifications

• Bachelor's degree in science, engineering, or related field with 5+ years in quality engineering.
• Experience applying FDA QSR/21 CFR Part 820, ISO 13485, and related standards.
• Ability to lead design controls, risk management, and design reviews.

Responsibilities

• Support new product development from inception through launch and maintenance.
• Ensure design/control documentation meets regulatory requirements.
• Lead quality improvements across processes and supplier quality.
• Perform audits and contribute to CAPA and continuous improvement.

Skills

Quality Systems

Design Control

Risk Management

Auditing

Statistical Methods

Process Validation

Software Validation

Regulatory Compliance

Education

Bachelor's degree in science/engineering

5 years of relevant experience

Tools

Quality software systems

Job description

Katalyst CRO seeks a Quality Engineer to support new product development and ongoing maintenance for medical devices. You will apply quality engineering principles to ensure products meet design control and regulatory requirements.

Active involvement in audits, risk management, and process validation will be required. The role emphasizes collaboration with cross-functional teams, adherence to quality standards, and contribution to continuous improvement initiatives to support product quality and