Quality Systems Engineer III

TekWissen • Austin, TX

24d • Hybrid

About The Position

The Quality Systems Engineer III ensures compliance with established product and process requirements and standards 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 and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, and corporate procedures and requirements. This is a four-month temporary assignment in Austin, Texas, with a hybrid work arrangement.

The role supports cross-functional teams in standardizing quality procedures, tools, and best practices across sites and regions. It also assesses gaps between local procedures and corporate requirements and applicable regulations, and collaborates with cross-functional team members to align and execute procedure updates. The duties listed are not exhaustive and may not comprise all essential functions for purposes of the Americans with Disabilities Act.

Requirements

• High school diploma or equivalent.
• Minimum 5 years of experience in Quality/Regulatory Compliance or a related field.
• Extensive knowledge of global medical device regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Experience developing and implementing procedures for QMS elements such as purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
• Familiarity with quality tools and methodologies such as Six Sigma, root cause analysis, risk management, statistical process control (SPC), and FMEA.
• Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders, including R&D and Regulatory.
• Previous medical device experience.
• Familiarity with Microsoft Office Suite.

Nice To Haves

• Bachelor's degree in Engineering.
• Technical, engineering, and/or scientific background.
• CQE or equivalent certification.
• Experience with enterprise quality systems and ERP systems, such as SAP and EtQ.
• Experience with SaMD (Software as a Medical Device) and Class II medical devices.

Responsibilities

• Support cross-functional teams in harmonizing and standardizing quality procedures, tools, and best practices across sites and regions.
• Complete 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 so they meet applicable requirements.
• Support development, implementation, and continuous improvement of the local Quality Management System.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED