Job Title - Quality Systems Engineer III
Duration - 5 Months
Location - Austin TX 78744 (Hybrid)
Summary:
Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (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.
Principal Duties and 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 & execute updates to local procedures to align with applicable requirements.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
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 but not limited to purchasing controls, design controls, non-conformance 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.
Education/Experience 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 related field required
CQE or equivalent certification preferred.
Must be familiar with Microsoft Office Suite.
Numbers & Facts
Location
Austin, TX
Skills
Best Practicesunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
ERP (Enterprise Resource Planning)unmatched
FDA (Food and Drug Administration)unmatched
Failure Mode and Effects Analysis (FMEA)unmatched
High School Diplomaunmatched
ISO (International Organization for Standardization)unmatched
International Electro-Technical Commission (IEC)unmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Medical Treatmentunmatched
Microsoft Officeunmatched
Procedure Developmentunmatched
Procedure Implementationunmatched
Procurement Managementunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Root Cause Analysisunmatched
SAPunmatched
Six Sigmaunmatched
Systems Engineeringunmatched
Team Playerunmatched
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