Quality System Specialist

Overview

As part of the global post market surveillance reporting team, the new colleague will be facilitating business data collection and reporting efforts and generating periodic product post market surveillance reports. This includes regular interactions with area subject mater experts to ensure data is collected, documented and analyzed in a timely and accurate manner. The person will use local and global systems to collect various post market information such as complaints, field corrective action and CAPA data. 

In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities. 

How You’ll Make an Impact: 

Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:   

• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and/or chair local/regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal/external audits as needed.
• Perform other related duties and assignments as needed.

What You Bring:  

• Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
• Experience in a regulated manufacturing industry or equivalent combination of education and experience
• Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
• Understanding of product post market surveillance requirements for IVD products a plus.
• Working knowledge of device/drug/biotech manufacturing processes.
• Detail-oriented and ability to multitask.
• Problem solving, decision making, time management, organization, communication, leadership, and computer skils.
• Advanced technical writing and word processing skills.
• Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus
• Fluent English, advanced language knowledge skills in reading and writing
• Strong Communication skills

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 usage for free of charge
• Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)