Senior Quality Systems Engineer (Medical Devices)

Katalyst CRO; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Quality/Regulatory Compliance professional to ensure QMS alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and related standards.

The role focuses on harmonizing local QMS across sites, implementing procedures, and ensuring regulatory conformance for medical devices including SaMD and class II devices. Strong collaboration with R&D and Regulatory is essential.

Qualifications

• Extensive knowledge of global regulatory requirements for medical devices (FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Experience developing and implementing quality procedures across sites and regions.
• Familiarity with quality tools and methodologies (Six Sigma, risk management, CAPA).

Responsibilities

• Support harmonization of quality procedures, tools, and best practices across sites.
• Complete gap assessments for local procedures against corporate requirements and regulations.
• Collaborate with cross-functional teams to update local procedures to meet applicable requirements.
• Adhere to established corporate QMS processes and regulatory standards.

Skills

Regulatory knowledge

Quality procedures

Cross-functional collaboration

Six Sigma

ERP systems

Medical device experience

SaMD and class II devices

Education

Bachelor's degree in Engineering

CQE certification

Tools

Microsoft Office

Job description

Katalyst CRO is seeking a Quality/Regulatory Compliance professional to ensure QMS alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and related standards.

The role focuses on harmonizing local QMS across sites, implementing procedures, and ensuring regulatory conformance for medical devices including SaMD and class II devices. Strong collaboration with R&D and Regulatory is essential.