Quality Systems Engineer

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. This is a 12-month hybrid temporary assignment located in Austin, TX 78744.

About the role

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, and 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, and EU MDR, as well as corporate procedures and requirements.

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 and execute updates to local procedures to meet applicable requirements.

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 a related field.
• Must be familiar with Microsoft Office Suite.

Skills

• 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 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.
• CQE or equivalent certification preferred.

Pay

$48.00–$54.00/hour