Job Summary:
We are looking for a highly motivated and experienced professional to join our team as a Quality Assurance Engineer within the Digital business in Budapest, Hungary. As part of this role you will be responsible for ensuring compliance with quality standards during the design, development, manufacture, testing and servicing of medical devices. You will work closely with cross-functional teams including engineering, production, purchasing, regulatory affairs and marketing to ensure products meet all relevant regulations and customer requirements. This position offers excellent opportunities for career growth within the organization.
This role is compatible with on site or hybrid role. Hybrid role allows candidate to work from home office 2 days per week and onsite 3 days per week.
Responsibilities:
• Ensure compliance with quality standards throughout the product lifecycle by implementing effective procedures and controls related to design, development, testing, and servicing of medical devices;
• Collaborate with cross-functional teams to identify potential risks or issues associated with product design/development, production processes, or post market surveillance activities;
• Conduct audits regularly to assess adherence to established protocols for quality management systems (QMS);
• Develop new methods or modify existing ones when necessary based on changing requirements or technological advancements;
• Work closely with internal stakeholders such as engineering, production, purchasing, regulatory affairs and sales teams to address any issues identified during audits or inspections promptly;
• Provide feedback on findings obtained from audits / inspections so appropriate actions can be taken to prevent recurrence of similar problems in future;
• Maintain product and site certifications through successful external audits;
• Lead audit readiness activities and represent GE HealthCare during external audits.
Qualifications:
• Bachelor’s degree in an engineering or technical discipline; or non-technical degree with a minimum 5 years of experience in manufacturing, engineering, or quality assurance.
• Minimum 3 years of experience working in a regulated industry.
• Strong knowledge base regarding Quality Management Systems (QMS);
• Excellent communication skills both written and verbal;
• Ability to work independently as well as collaboratively across multiple disciplines;
• Proficiency in Microsoft Office Suite applications (Word, Excel, PowerPoint etc.) essential;
• Experience working with SAP system beneficial but not essential;
• Knowledge of ISO 13485, ISO 14971, 21CFR820, and other relevant international standards advantageous;
• Fluent English language skills essential – further languages beneficial but not essential;
• Willingness to travel occasionally if needed (