Design Quality Engineer - Medical Devices

Enovis; Austin (TX); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

Enovis is seeking a Quality Assurance Engineer – Design Quality Focus in Austin, TX. You will drive quality systems, perform risk analyses, and support design reviews while ensuring compliance with ISO 13485 and FDA requirements. The role requires collaboration with cross-functional teams and hands-on evaluation of design documentation.

Responsibilities include authoring procedures, leading audits, and improving manufacturing and product quality processes. Travel up to 10% may be required.

Competenze

• Bachelor's degree in Biomedical or Mechanical Engineering; 3+ years in a design-focused environment.
• Experience in Medical Device or other highly regulated industries; ISO13485 knowledge preferred.
• Strong technical writing and quality systems understanding.
• Knowledge of manufacturing processes including metrology, precision machining, grinding, cleaning, and sterilization.

Mansioni

• Participate in design and manufacturing reviews.
• Generate DFMEAs/UFMEAs and contribute to risk analysis discussions.
• Review and approve design and development documentation.
• Serve as QA subject matter expert for ISO and FDA audits.
• Author procedures and work instructions for the quality system.
• Conduct internal audits of the quality system and other functions.
• Evaluate nonconforming material and disposition decisions.

Conoscenze

Design quality

Risk analysis

Technical writing

Regulatory knowledge

Metrology

Formazione

Biomedical or Mechanical Engineering degree

Strumenti

Solidworks

Solidworks ePDM

Oracle R12

Agile PLM

Descrizione del lavoro

Enovis is seeking a Quality Assurance Engineer – Design Quality Focus in Austin, TX. You will drive quality systems, perform risk analyses, and support design reviews while ensuring compliance with ISO 13485 and FDA requirements. The role requires collaboration with cross-functional teams and hands-on evaluation of design documentation.

Responsibilities include authoring procedures, leading audits, and improving manufacturing and product quality processes. Travel up to 10% may be required.