Quality Systems Engineer III

Job Title: Quality Systems Engineer III Location: Austin, TX 78758 Duration: 10 Months Job ID: 36836798 Pay Range: $45-50/hr on W2 Job Description: Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). This role supports the global development, implementation, continuous improvement, and harmonization of the local QMS in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, and corporate procedures. Must Have (Minimum Requirements) Minimum 5+ years of experience in Quality, Regulatory Compliance, or related field. Extensive knowledge of global regulatory requirements for medical devices (21 CFR Part 820, ISO 13485, EU MDR, IEC 62304). Experience developing and implementing QMS procedures for purchasing controls, design controls, nonconformance management, validation, and CAPA. Strong collaboration and communication skills to align cross-functional stakeholders. Familiarity with Client Office Suite. Previous experience in the medical device industry. Nice to Have (Preferred Requirements) Bachelor s degree in engineering, technical, or scientific field. CQE (Certified Quality Engineer) or equivalent certification. Experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ). Familiarity with SaMD (Software as a Medical Device) and class II medical devices. Experience with quality tools and methodologies (Six Sigma, root cause analysis, risk management, SPC, FMEA). Responsibilities / Day-to-Day Activities Support cross-functional teams in harmonizing and standardizing quality procedures, tools, and best practices across sites and regions. Conduct gap assessments of 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 meet applicable requirements. Ensure QMS implementation supports compliance, continuous improvement, and regulatory expectations. Maintain documentation and support audits as needed. Impact / Differentiating Factors Autonomy: Works independently to implement QMS processes and harmonization projects with minimal supervision. Organizational Impact: Influences cross-functional teams to align with regulatory requirements and quality standards. Communication: Acts as a liaison between R&D, regulatory, and quality teams to ensure consistent application of standards. Innovation: Recommends enhancements to processes to improve QMS effectiveness and compliance.