Quality System Specialist

In alignment with Global RA/QA strategic aims, this position manages the Quality Management System for Budapest to ensure the QMS is maintained in compliance with all applicable quality and regulatory requirements. Our new colleague will promote best practices to achieve process efficiencies, to ensure customer satisfaction and optimal value to the business and being an active team member in the EMEA QMS. 

How You will make an impact:  

• Maintenance and improvement of the Quality Management System (e.g., ISO 9001, ISO13485, IVDR) in accordance with Global RA/QA goals and Budapest business needs. 
• Manage the document control process: Quality Manual, procedures, and work instructions. 
• Identify and implement improvements in applicable procedures; monitor and measure post-implementation with the appropriate indicators. 
• Plan and lead applicable quality reviews with local managers and ensure any resulting actions taken have been effectively implemented.  
• Report to management on the performance of the QMS and any need for improvement. 
• Mentor and train employees on the QMS, work collaboratively with business partners on quality requirements and changes in the regulatory landscape. 
• Identify improvement opportunities by conducting internal audits and from the analysis of customer feedback data and KPIs. Support the business to define corrective and preventive actions and improvement activities. 
• Manage external audits by Notified Bodies and customers. 
• Ensure that Quality and Regulatory obligations for channel partners are managed effectively. 
• Remain current on evolving QMS trends and product regulatory requirements 
• Participate in the internal EMEA audit program as either lead auditor or auditor. 
• Support EMEA QA-related projects according to defined objectives to maintain and improve the EMEA QMS. 
• Travel as needed to support EMEA QMS activities and requirements. 

What You’ll bring:   

• Education: Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent, with further education a plus. 
• Language knowledge: Fluent in English and Hungarian, Russian language would be a huge plus
• Minimum 5 years QMS experience in an ISO13485 regulated environment, medical device or life science preferred. 
• Strong working knowledge of ISO9001, ISO13485.  Additional knowledge of FDA 820 CFR and IVDR a plus. 
• Proven experience with CAPA, Documentation Management, Change Control, Training. 
• QMS auditing experience, certified quality auditor preferred. 
• Detail-oriented, critical thinking, and ability to multitask. 
• Strong problem solving, decision making, time management, organization, communication, leadership, and computer skills. 
• Proven leadership and influencing skills in a cross-cultural, matrixed organization. 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer a variety of options, including:  

• Life and accident insurance, 
• Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge 
• Competitive salary and cafeteria 
• 100% commuting allowance for non Budapest residents and free BKK monthly pass
• Annual bonus 
• Annual salary review 
• Marriage and childbirth allowance 
• School start allowance 
• Loyalty award 
• Employee Referral Program with remarkable referral bonus 
• All You Can Move contract possibility/gym facility discount 
• Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)