Quality System Specialist III

Responsibilities

• Facilitate and generate product Post Market Surveillance (PMS) and PSUR reports
• Analyze post market data and review completed reports with business partners
• Maintain and support databases and systems used for tracking QMS activities related to post market surveillance
• Maintain and archive completed controlled quality records
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners
• Facilitate or chair local/regional PMS Board meetings
• Support various QMS and PMS projects and assist with internal/external audits

Requirements

• Bachelor’s degree in a life science, technical, or engineering discipline
• Experience in a regulated manufacturing industry
• Understanding of GMP and quality system standards
• Advanced technical writing and word processing skills
• Strong communication, problem-solving, and organizational skills
• Proficiency in English (reading and writing)

Preferred Qualifications

• Understanding of product post market surveillance requirements for IVD products
• Working knowledge of device, drug, or biotech manufacturing processes
• Experience with electronic QMS systems such as Veeva, EtQ, or Trackwise

Benefits

• Hybrid working model (3 days onsite, 2 days home office)
• Private Health Care Services with unlimited examinations and checkups
• Competitive salary and annual bonus
• Annual salary review and loyalty awards
• Life and accident insurance
• Commuting allowance for non-Budapest residents
• Various allowances (marriage, childbirth, and school start)
• Employee Referral Program

About the Company

Bio-Rad is a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. For 70 years, we have focused on advancing the discovery process and transforming the fields of science and healthcare to help people live longer, healthier lives.