Quality Systems Engineer III

Aequor; Austin (TX); On-site; Full time

Job summary

A medical device company located in Austin, Texas is seeking a Quality Management System specialist. This role involves ensuring compliance with medical device regulations and standards, supporting the implementation of Quality Management Systems, and collaborating with cross-functional teams for harmonization. Candidates should have a strong background in regulatory requirements like ISO 13485, experience with quality tools, and prior experience in the medical device field.

Qualifications

• Extensive knowledge of global regulatory requirements for medical devices.
• Skilled in developing and implementing QMS procedures.
• Familiarity with quality tools like Six Sigma and root cause analysis.

Responsibilities

• Ensure compliance with established requirements and standards.
• Support the development of a harmonized Quality Management System.
• Collaborate with teams to update local procedures according to requirements.

Skills

Global regulatory requirements knowledge

Procedure development and implementation

Quality tools and methodologies familiarity

Communication and collaboration skills

Medical device experience

Tools

SAP

EtQ

Job description

Responsibilities

• 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.
• 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.

Experience

• 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, 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.