Quality System Specialist - Design Quality

Responsibilities

• Partner cross-functionally to provide Design Quality support for New Product Development and design changes across the product lifecycle.
• Ensure Design Quality activities comply with applicable regulatory and quality standards, including ISO 13485, IVDR, FDA, and ISO 14971.
• Provide guidance to global teams to ensure consistent application of quality processes and effective maintenance of Design History Files (DHFs).
• Ensure design deliverables, including DHFs and Risk Management documentation, meet internal and external regulatory requirements.
• Drive continuous improvement of global Design Quality processes and participate in design reviews and audits.
• Collaborate with Post Market Surveillance (PMS) and Risk Management partners to ensure design changes and risk profiles are appropriately documented.

Requirements

• Master’s degree in a health sciences, life sciences, or engineering discipline.
• 3–4 years of direct experience in a quality role supporting Design Controls.
• High proficiency in ISO 13485, ISO 14971, MDSAP, and IVDR requirements.
• Experience supporting multi-site projects.
• Fluent in English; proficiency in French is a plus.
• Strong technical knowledge, attention to detail, and ability to guide stakeholders pragmatically.

Benefits

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

About the Company

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As 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.