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 will make an impact:
- Coordinate the completion of Initial Technical Assessments (ITA) related to product design changes with various subject matter experts (SME) and cross functional stakeholders.
- Support the global design control programs by ensuring deliverables related to product design changes are completed in accordance with global and local quality system requirements and Bio-Rad procedures and policies. This includes following up with appropriate SMEs/stakeholders and ensuring project team member training plans/records are up to date.
- Facilitate the initiation and routing of Design History File (DHF) deliverables in the global eQMS system and ensuring appropriate reviewers and approvers are assigned. This includes ensuring appropriate document formatting and version controls.
- Work with sustaining project teams to assess the status of legacy product DHFs and coordinate updates according to project plans/timelines.
- Coordinate updates to product risk management files as needed per completed ITAs and project outcomes.
- Support the global Design Quality Assurance team by acting on requests as assigned by the supervising Quality Engineering. Complete tasks as assigned with the understanding that as the candidate learns and develops, so shall the responsibilities and level of complexity of assignments.
- 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.
- Being ambitious and thoughtfully engaged in the assignments to foster learning and comprehension of the business and associated standards and regulations in the IVD industry.
- Exhibiting a high level of emotional intelligence, patience and support to teams which are managing shifting priorities.
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
- 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
- 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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