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Director of Design Quality & Risk Management
Job in
Andover, Essex County, Massachusetts, 05544, USA
Listed on 2026-09-04
Listing for:
Ivenix, Inc.
Full Time, Part Time
position Listed on 2026-09-04
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Fresenius Kabi in the United States seeks a Director of Design Assurance & Site Quality to lead the Design Center's quality functions, own the site QMS, and ensure products meet FDA, MDR, and ISO requirements throughout their lifecycle.
This role drives Design Controls, Risk Management, DfX, Design Transfer, Supplier Quality, and audit readiness, while fostering a culture of right‑first‑time quality. Hybrid onsite 3 days/week; salary range $185,000–$205,000.
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