Quality Systems Engineer III

Katalyst CRO; Austin (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO in Austin, Texas is seeking a Quality Management System Specialist to ensure compliance with medical device regulations. This role involves supporting the development and implementation of the Quality Management System (QMS) and requires extensive knowledge of FDA regulations, ISO standards, and quality management procedures. Candidates should have a Bachelor’s degree in Engineering and at least 5 years of experience in Quality/Regulatory Compliance. Strong communication skills and familiarity with ERP systems are preferred.

Qualifications

• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required.
• CQE or equivalent certification preferred.
• Technical, engineering, and/or scientific background is strongly preferred.

Responsibilities

• Ensure compliance with established requirements through implementation of the QMS.
• Support global development and improvement of the local QMS.
• Complete gap assessments for local procedures against regulations.
• Collaborate with teams to execute updates to local procedures.

Skills

Knowledge of global regulatory requirements for medical devices

Development and implementation of quality management procedures

Collaboration and communication skills

Familiarity with quality tools (Six Sigma, root cause analysis)

Education

Bachelor's degree in Engineering

High school diploma or equivalent

Tools

Microsoft Office Suite

ERP systems (e.g., SAP, EtQ)

Job description

Responsibilities

• 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.
• 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 and 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.

Competencies and Preferred Experience

• 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 (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

• 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.