Quality System Specialist

Now Hiring: Quality Systems Specialist (Medical Devices) Client Industry: Orthopedic Medical Devices & Musculoskeletal Healthcare Contract Duration - 10 months/W2 We are hiring a Quality Systems Specialist to support a leading global organization in the orthopedic medical device sector. This role focuses on ensuring compliance, harmonization, and continuous improvement of the Quality Management System (QMS) in alignment with global medical device regulations. Key Responsibilities Support global development, implementation, and continuous improvement of the Quality Management System (QMS). Conduct gap assessments of local procedures against corporate policies and global medical device regulations. Partner cross-functionally with R&D and Regulatory teams to update and align quality procedures. Drive harmonization and standardization of quality processes across sites and regions. Ensure compliance with applicable regulatory standards and internal requirements. Required Experience & Skills 5+ years of experience in Quality or Regulatory Compliance within the medical device industry . Strong knowledge of: FDA 21 CFR Part 820

ISO 13485

EU MDR

ISO 14971

Hands-on experience with QMS elements including: Design Controls CAPA Nonconformance Management Purchasing Controls Validation Familiarity with quality tools such as Six Sigma, FMEA, SPC, and root cause analysis. Experience with enterprise systems such as SAP and EtQ Reliance preferred. Experience with Software as a Medical Device (SaMD) and Class II devices is a plus. Bachelor’s degree in Engineering or related technical field preferred. #J-18808-Ljbffr Swoon