Quality Lead Specialist 1
3 days ago
Job Description SummaryDevelop 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 DescriptionJob 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 (
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Quality Lead Specialist 1
5 days ago
Budapest, Budapest, Hungary GE HealthCare Full time 9,000,000 - 12,000,000 per yearJob Description SummaryDevelop 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...
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Quality and Regulatory Specialist
7 days ago
Budapest, Budapest, Hungary SOFMEDICA Life-saving Innovation Full time 400,000 - 800,000 per yearSOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe.We are looking for a Quality and Regulatory Specialist to join...
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Quality Assurance Specialist
7 days ago
Budapest, Budapest, Hungary Carbyne Full time 40,000 - 80,000 per yearOur USA-based Global Big Pharma partner is looking for an additional team member to fill the role of Quality Assurance Specialist / Responsible Person in Hungary. This is a great opportunity to deepen your professional knowledge on pharmaceutical product release for the local and other EU markets.Your tasks will be:Work closely with the Hungary Quality team...
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Quality Project Specialist
3 days ago
Budapest, Budapest, Hungary Partner in Pet Food (PPF) Full time €45,000 - €90,000 per yearPartner in Pet Food (PPF) is an innovative, leading European pet food producer, supplying over 600 customers, including major grocery retailers, supermarkets, specialized pet shops in the 40 markets in which it operates.PPF is the second largest producer of Retailer Brand wet and dry pet food in Europe, offering a full range of high quality cat and dog food...
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Quality Assurance Specialist
7 days ago
Budapest, Budapest, Hungary Carbyne Full time €40,000 - €60,000 per yearOur Global Big Pharma partner is looking for an additional team member to fill the role of Quality Assurance Specialist / Responsible Person in Hungary. This is a great opportunity to deepen your professional knowledge on pharmaceutical product release for the local and other EU markets.Your tasks will be:Work closely with the Hungary Quality team to...
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Budapest, Budapest, Hungary Carbyne Full time €40,000 - €60,000 per yearOn behalf of our client, a global market leading IVD company, we are looking for a fixed term (12 months) Quality System Specialist.This Specialist role will be responsible for assisting in the collection and reporting of Quality data, as well as producing periodic post-market surveillance reports for products. As Quality System Specialist, your key...
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Budapest, Budapest, Hungary Carbyne Full time 40,000 - 80,000 per yearOur partner a global market leading IVD company is looking for its newest member to join their team in Budapest as Quality System Specialist. This Senior Specialist role will be focusing on QMS data management and the local implementation of the company's new global QMS system.As Quality System Specialist, your key tasks will include:Quality data...
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Budapest, Budapest, Hungary Carbyne Full time €1,200,000 - €2,400,000 per yearOur partner a global market leading IVD company is looking for its newest member to join their team in Budapest as Quality System Specialist. This Senior Specialist role will be focusing on QMS data management and the local implementation of the company's new global QMS system.As Quality System Specialist, your key tasks will include:Quality data...
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Supplier Quality Specialist
7 days ago
Budapest, Budapest, Hungary Richter Gedeon Nyrt. Magyarország Full time 3,600,000 - 4,500,000 per yearA Richter GedeonSupplier Quality Specialistmunkatársat keres.Csatlakozz hozzánkA Supplier Quality Specialist munkatárs fő célja a beszállítók által szállított termékekkel és anyagokkal kapcsolatos reklamációk szakszerű kezelése, valamint a beszállítói minőség folyamatos fejlesztésének támogatása.A Supplier Quality Coordinator...
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Supplier Quality Specialist
7 days ago
Budapest, Budapest, Hungary Richter Gedeon Nyrt. Full time 1,800,000 - 3,600,000 per yearGyere és csatlakozz a 120 éves Richter Gedeon Nyrt. csapatához, Magyarország és a régió meghatározó gyógyszeripari vállalatáhozKivételes helyzetünket annak köszönhetjük, hogy sohasem pihenünk meg a sikereinken, hanem mindig a következő lehetőséget kutatjuk. A lehetőséget, hogy újabb területeket hódítsunk el az ismeretlentől és...
