Senior Quality Engineer, Medical Devices

Regulatory Jobs; Highland (IN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

None

Zusammenfassung

ICU Medical is seeking a Quality Engineer to provide quality support for product development, ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820 and related standards. The role covers system, hardware, software and consumable components to ensure the highest level of quality as products are developed.

You will participate in risk analyses, CAPA, design verification, and cross-functional reviews while aligning with development practices.

Qualifikationen

• Must have a bachelor's degree in engineering or related field.
• ASQ CQE or CSQE certification or ability to obtain within 12 months.
• Experience in medical device quality engineering and regulatory frameworks.

Aufgaben

• Ensure product safety and quality throughout the lifecycle.
• Maintain compliance with ICU Medical quality system and development practices.
• Utilize quality tools for risk analysis, validation, V&V and CAPA.
• Prepare for internal/external audits and inspections.
• Lead design reviews, risk assessments, and cross-functional collaboration.
• Review qualification of software and software tools.
• Support regulatory submissions and inquiries.

Kenntnisse

Quality compliance

Audit skills

Investigation skills

Quality management systems

Risk management

Cross-functional teamwork

Design controls

Ausbildung

Bachelor's degree in engineering

ASQ CQE or CSQE certification

Tools

CAPA systems

Audit management tools

Jobbeschreibung

ICU Medical is seeking a Quality Engineer to provide quality support for product development, ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820 and related standards. The role covers system, hardware, software and consumable components to ensure the highest level of quality as products are developed.

You will participate in risk analyses, CAPA, design verification, and cross-functional reviews while aligning with development practices.