Senior Medical Device Quality Engineer – Regulatory & Risk

Katalyst CRO; Santa Clara (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.

This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global

Qualifications

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• ASQ Certified Quality Engineer (CQE) certification is preferred.
• Minimum 6 years of experience in the Medical Device industry.
• Experience working in highly regulated manufacturing environments.
• Experience supporting product development, manufacturing, and quality engineering activities.
• Experience managing complaint handling and Post Market Surveillance (PMS) activities.
• Experience managing Non-Conformance (NC), CAPA, and quality investigations.
• Experience supporting internal, external, and regulatory audits.

Responsibilities

• Lead design transfer and production support activities while ensuring compliance with FDA regulations and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives throughout product development programs.
• Manage quality activities for assigned product components and subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA implementation within the Quality Management System (QMS).
• Develop, maintain, and update Design, Process, Application, and System FMEAs while supporting risk mitigation activities.
• Support qualification and validation activities, including IQ, OQ, and PQ.
• Identify, evaluate, and implement compliant solutions for engineering and manufacturing challenges.
• Maintain and continuously improve Quality Management System (QMS) processes.
• Collaborate with Engineering, Manufacturing, Operations, and Quality teams to resolve product and process issues.
• Interpret and apply FDA regulations, ISO standards, and medical device quality requirements throughout the product lifecycle.
• Support internal, external, customer, and regulatory audits and ensure timely closure of audit findings.
• Utilize statistical tools and data analysis techniques to improve product quality, reliability, and manufacturing processes.
• Ensure compliance with medical device quality standards and regulatory requirements across all quality engineering activities.

Skills

Medical Device Quality Systems

ISO 13485

FDA 21 CFR Part 820

Risk Management ISO 14971

CAPA

Quality Assurance

Design Transfer

Statistical Methods

Education

Bachelor's degree in mechanical engineering

ASQ CQE certification

Tools

QMS

Job description

Katalyst CRO is seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.

This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global