Quality System Specialist - 2 years fixed-term

The new colleague will support Bio-Rad’s commitment to quality and safety by managing activities related to the review, evaluation and investigation of escalated customer complaints related to Bio-Rad’s Life Science Group product portfolio. 

How You’ll make an impact:

• Being impeccable with their attention to detail and able to adopt and promote audit readiness for documents and records.
• Maintaining the confidence and assertiveness required to approach and collaborate with global stakeholders on action items and support.
• Staying nimble and applying critical thinking to assignments to quickly identify and address potential gaps or inconsistencies across a number of projects or platforms.
• Exhibiting a high level of emotional intelligence, patience and support to teams which are managing shifting priorities.

The candidate will be under the supervision of the Global Design Quality Assurance Manager and will:

• Support various New Product Development projects by ensuring the design control process is followed and ensure product design history files (DHF) are completed and maintained prior to product launch.
• Support the Design Quality Engineers as needed by supporting design and development phase closure DHF audits and acting as a subject matter expert for electronic document management system workflows (Veeva, EtQ, etc.).
• Coordinate and facilitate the creation and maintenance of project risk management files during the new product development process and ensure files are complete prior to launch.
• Support the creation and maintenance of the Design Quality Assurance NPD Playbook in coordination with the global Design Quality Assurance Manager and Design QEs.

What You’ll bring:

• Associate degree or equivalent in a related technical discipline (Engineering, Chemistry, Biology, Computer Science), Bachelor’s degree preferred.
• 2+ years experience or equivalent combination of education and experience within a regulated industry
• Basic knowledge and application of principles and theories of risk management and quality assurance or quality engineering.
• Working knowledge of medical device/drug/biotech manufacturing and design and development
• Excellent communication and time management skills, fluent in English
• Understanding of ISO 14971 and ISO 13485 preferred
• Experience with electronic Quality Management Systems (eQMS) such as EtQ, Trackwise, Veeva, etc. preferred.

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  
• 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) 

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