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# Quality Systems Engineer

- **Company:** Internash Global Services, LLC
- **Location:** Austin, TX, United States
- **Experience:** Expert
- **Salary:** $104,000.0 - $108,160.0
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Microsoft Office, SAP (Applications), Statistical Process Control (SPC)
- **Published:** June 29, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=982c11d892a1d547

## About the Role

Do you have a valid Certified Quality Engineer certification?, Do you have experience in Six Sigma methodology implementation?, * 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance within the Medical Device industry.

 * Strong knowledge of:
 * FDA 21 CFR Part 820
 * ISO 13485
 * EU MDR
 * ISO 14971
 * IEC 62304
 * Experience developing and implementing Quality Management System (QMS) procedures.
 * Hands-on experience with CAPA, Design Controls, Purchasing Controls, Validation, and Non-Conformance Management.
 * Familiarity with quality tools and methodologies including Root Cause Analysis, Risk Management, FMEA, SPC, and Six Sigma.
 * Experience collaborating with cross-functional teams including Quality, Regulatory Affairs, and R&D.
 * Proficiency with Microsoft Office Suite., * Previous experience in the Medical Device industry is required.
 * Experience with Software as a Medical Device (SaMD) and/or Class II Medical Devices is preferred.
 * Experience with enterprise quality systems such as SAP or EtQ.
 * Bachelor's degree in Engineering, Science, or a related technical discipline preferred.
 * CQE or equivalent quality certification is a plus., * Quality Management System (QMS)
 * FDA 21 CFR Part 820
 * ISO 13485
 * IEC 62304
 * EU MDR
 * ISO 14971
 * CAPA
 * Design Controls
 * Validation
 * Risk Management
 * FMEA
 * Root Cause Analysis
 * Medical Device Compliance
 * SAP / EtQ
 * Cross-Functional Collaboration

If you have strong experience supporting Quality Systems in a regulated medical device environment and are passionate about driving compliance and continuous improvement, we'd love to hear from you.

## Description

* Support the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
 * Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, ISO 14971, and corporate quality procedures.
 * Perform gap assessments of local procedures against corporate standards and regulatory requirements.
 * Collaborate with cross-functional teams to update and standardize quality procedures, tools, and best practices.
 * Support QMS elements including Design Controls, Purchasing Controls, Validation, Non-Conformance Management, CAPA, and Change Control.
 * Drive continuous improvement initiatives to strengthen quality systems and regulatory compliance.
 * Partner with Regulatory Affairs, R&D, and Quality teams to ensure alignment with quality objectives.


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