Quality System Engineer

Location: Austin
Industry: Medical Devices
Employment Type: Full-time

We are seeking a Quality System Engineer to ensure compliance with established requirements and standards for products and processes through the effective implementation and continuous improvement of the Quality Management System (QMS).

In this role, you will support the global development, implementation, harmonization, and continuous improvement of the local QMS in compliance with applicable medical device regulations and standards, including:

• U.S. Food and Drug Administration 21 CFR Part 820
• ISO 13485
• IEC 62304
• European Union Medical Device Regulation (EU MDR)
• Corporate procedures and internal quality requirements

This position plays a key role in driving regulatory compliance and quality excellence across sites and regions.

Principal Duties and Responsibilities:

• Support cross-functional teams in harmonizing and standardizing quality procedures, tools, and best practices globally.
• Conduct gap assessments of local procedures against corporate standards and applicable medical device regulations.
• Collaborate with cross-functional stakeholders (R&D, Regulatory, Operations) to update and align local procedures with regulatory and corporate requirements.
• Contribute to continuous improvement initiatives within the QMS framework.
• Ensure documentation and processes meet regulatory and audit expectations.

• Extensive knowledge of global medical device regulatory requirements, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Strong experience developing and implementing QMS procedures, including:
  • Purchasing controls
  • Design controls
  • Nonconformance management
  • Validation
  • Corrective and Preventive Actions (CAPA)
• Proficiency with quality tools and methodologies such as:
  • Six Sigma
  • Root cause analysis
  • Statistical Process Control (SPC)
  • Failure Mode and Effects Analysis (FMEA)
• Strong communication and collaboration skills with the ability to influence cross-functional stakeholders (R&D and Regulatory teams).
• Experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ) preferred.
• Previous experience in the medical device industry is mandatory
  .
• Experience with Software as a Medical Device (SaMD) and Class II medical devices is preferred.

• High school diploma or equivalent required.
• Bachelor’s degree in Engineering preferred.
• Technical, engineering, or scientific background strongly preferred.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or a related field.
• Certified Quality Engineer (CQE) or equivalent certification preferred.
• Proficiency with Microsoft Office Suite required.

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (after works, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.