Quality Lead Specialist 1 - Healthcare Quality
Quality Lead Specialist 1 - Healthcare Quality
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Job Description
Job Description Summary
Develop and maintain systems rules and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the marketJob Description
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:
Bachelors 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 ISOCFR820 and other relevant international standards advantageous;
Fluent English language skills essential further languages beneficial but not essential;
Willingness to travel occasionally if needed (<10%);
Additional Information
Relocation Assistance Provided: No
Required Experience:
Unclear Seniority
Employment Type
Full-Time
