Quality System Specialist

Quality System Specialist

Bio-Rad

Budapest, Hungary

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.