AllSTEM Connections is actively recruiting on behalf of one of our valued clients—a leading organization known for innovation and excellence in the digital product space. We are excited to share this opportunity with professionals who are passionate about design systems, user experience, and collaborative product development. If the role aligns with your background and career goals, we encourage you to apply and take the next step toward joining a dynamic and forward-thinking team.
Position Title – Quality Systems Engineer III
Hourly Pay Rate (w2 Role) - USD 50 /hr - USD 55 /hr
Contract End Date - 12/31/2026
Hybrid Schedule
Location - Austin , TX 78744
Hybrid - 3 days in office, 2 remote
Job Summary
Quality Systems Engineer III – Job Description
This role is responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). The position supports the global development, implementation, continuous improvement, and harmonization of local QMS processes in compliance with applicable medical device regulations, standards, and internal quality procedures.
Key Responsibilities
- Support cross-functional teams in harmonizing and standardizing quality procedures, tools, and best practices across multiple sites and regions.
- Perform gap assessments of local procedures against corporate standards, regulatory requirements, and applicable medical device regulations.
- Collaborate with stakeholders across R&D, Quality, and Regulatory teams to implement procedural updates and ensure regulatory alignment.
- Support compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR requirements.
- Contribute to continuous improvement initiatives within the Quality Management System.
- Maintain documentation in accordance with internal and external audit requirements.
Required Skills and Competencies
- Strong knowledge of global medical device regulations and quality system requirements.
- Experience developing, implementing, and maintaining QMS procedures such as design controls, purchasing controls, CAPA, validation, and nonconformance management.
- Proficiency with quality tools and methodologies (e.g., risk management, root cause analysis, Six Sigma, SPC, FMEA).
- Strong communication and collaboration skills with the ability to influence cross-functional teams.
- Experience using enterprise quality systems and ERP platforms (e.g., EtQ, SAP).
- Prior experience in the medical device industry is required; experience with SaMD and Class II devices is preferred.
Education and Experience
- High school diploma or equivalent required.
- Bachelor’s degree in Engineering or a technical/scientific discipline preferred.
- Minimum of 5+ years of experience in Quality, Regulatory, or Compliance roles within regulated industries.
- CQE or equivalent certification preferred.
- Proficiency with Microsoft Office Suite.