Overview:
The Quality System Specialist supports and performs activities associated with processes that make up the Quality Management System (QMS). This includes but is not limited to change control, CAPA, audit (internal/external) and management review meeting.

• Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred.
• ISO 13485:2016 Lead Auditor certified preferred
• At least 2+ years experiences in a regulated manufacturing industry or equivalent combination of education and experience.
• Experience with QMS Databases (i.e., Veeva, SAP).
• Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
• Strong communication and coordination skills across cross-functional and global teams.
• Decision making, time management, organization and computer skills.
• Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes.
• Detail-oriented and ability to multitask