Job Description Summary

GE Healthcare in Herlev Denmark is seeking a Quality Assurance Engineer to join our dedicated team of experienced Design Quality Assurance Engineers, where we design and manufacture ultrasound medical device systems that impact patient care globally.

This is an exciting opportunity to work on cutting-edge technology in a collaborative, fast-paced, and innovation-driven environment. Based in Herlev, you’ll be part of a team that values continuous learning and offers professional development and training opportunities to help you grow in your role.

Together with the team, you’ll ensure that our products and projects meet both internal and external requirements through robust systems and processes. Your focus will be on quality— ensuring that design changes, CAPA activities, and other QA operations are handled with precision and with patient safety in focus.

This is a key technical and collaborative position where you’ll provide engineering process support in accordance with documented procedures and industry standards. You’ll work alongside talented engineering and manufacturing professionals and play a central role in the development, implementation, and continuous improvement of our Quality Management System, product specifications, and applicable regulatory requirements. Your work will span across design control, CAPA, external and internal audits, and manufacturing, and you’ll apply a deep understanding of business drivers to ensure that quality is built into every stage of the product lifecycle.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• Collaborate with engineering and manufacturing functions to ensure compliance with quality standards and regulatory requirements across the product lifecycle.

• Lead and coordinate quality assurance activities, with a strong focus on design changes, CAPA management, and continuous improvement initiatives. Leverage internal resources and cross-functional collaboration to support decision-making and drive quality outcomes.

• Champion a quality culture by driving compliance activities related to specific products, sites, or regions.

• Support internal and external audits, ensuring timely resolution of findings and maintaining audit readiness across relevant areas.

• Develop in-depth knowledge of quality disciplines and apply prior experience and technical expertise to execute functional strategies and policies.

• Operate as an individual contributor with strong interpersonal skills and communicating effectively with colleagues outside and inside of the quality organisation.

• Influence projects, processes, and procedures within your field of expertise, exercising sound judgment and working with a degree of autonomy within established practices.

• Apply technical expertise and analytical thinking to solve problems

Required Qualifications

• Bachelor’s degree in life sciences, engineering, or related field

• 1-3 years of experience in medical device or regulated industry

Desired Characteristics

• Master’s degree in life sciences, engineering, or related field

• Enthusiasm, high attention to detail and eager to learn

• Strong communication and collaboration skills across functions

• High experience working with ISO 13485, FDA 21 CFR Part 820 and MDR

• Experience with supporting internal and external audits following MDSAP

• Proficiency in quality tools such as CAPAs, Non-conformances, and Design Control.

• Fluency in English

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information