Quality Engineer - Medical Devices & Risk Management

Ambu A/S; Noblesville (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Ambu A/S is seeking a Quality Engineer in Noblesville, Indiana, to support product development and ensure compliance with design controls and risk management in the medical device sector. The ideal candidate will have experience with ISO standards and quality management systems.

Your role will include maintaining the Quality Management System, addressing quality issues, and supporting the development of improvement procedures. A bachelor's degree in engineering and relevant experience in quality engineering is required.

Qualifications

• 1 – 5 years of experience in quality and/or quality engineering roles within the medical device industry.
• Hands-on experience with design controls and risk management, including FMEA.
• Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 standards.

Responsibilities

• Maintain, monitor, and improve the Quality Management System (QMS).
• Implement effective quality control systems for manufacturing and product development.
• Support CAPA verification and manage product and process risk management activities.

Skills

Experience with ISO 13485

Analytical and problem-solving skills

Ability to travel nationally and internationally

Effective verbal and written communication skills

Proficient with Microsoft Office

Education

Bachelor's degree in Engineering or technical field

Job description

Ambu A/S is seeking a Quality Engineer in Noblesville, Indiana, to support product development and ensure compliance with design controls and risk management in the medical device sector. The ideal candidate will have experience with ISO standards and quality management systems.

Your role will include maintaining the Quality Management System, addressing quality issues, and supporting the development of improvement procedures. A bachelor's degree in engineering and relevant experience in quality engineering is required.