Quality Systems Engineer III - Medical Devices Compliance

Aequor; Austin (TX); On-site; USD 85,000 - 120,000; 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

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.