Quality Systems Engineer III

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

• Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
• The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
• What You Can Expect How You'll Create Impact Principal

Summary

• Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
• The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
• What You Can Expect How You'll Create Impact Principal

Roles and Responsibilities

• Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
• Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.
• Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.
• This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
• What Makes You Stand Out Expected Areas of Competence (i.e., knowledge, skills and abilities)
• Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
• Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).
• Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ).
• Must have previous Medical Device Experience
• Preferred experience with SaMD (Software as a medical device) and class II medical devices.

Education & Experience

• Your Background Education/Experience Requirements
• High school diploma or equivalent required.
• Bachelor's degree in Engineering preferred.
• Technical, engineering, and/or scientific background is strongly preferred.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required
• CQE or equivalent certification preferred.
• Must be familiar with Microsoft Office Suite.