It Specialist - Quality Systems Ari

It Specialist - Quality Systems
Ari
Abruzzo, Ari

Join us today and make a difference in people's lives!

Join a leader in medical technology, where we're dedicated to advancing patient care through innovation and unwavering commitment to quality.

Our work supports the highest standards of quality and compliance, and we're looking for an experienced IT Specialist - Quality Systems to help drive these standards forward.

As an IT Specialist - Quality Systems, you'll serve as a vital bridge between our IT and Quality departments, focusing on optimizing and managing key systems and processes within Quality Management, Document Control, CAPA, Supplier Quality, and Non-Conformance Reports (NCRs).

You'll work closely with cross-functional teams to support global MedTech initiatives, enhancing compliance, efficiency, and overall quality.

Duties and Responsibilities Business Analysis: Engage with stakeholders to understand business requirements, translate them into technical specifications, and collaborate with IT and quality teams to ensure proper implementation.

System Support & Optimization: Manage and optimize quality-related systems, particularly SAP QM, IQVIA, and other relevant platforms.

Quality Processes: Support and enhance processes related to CAPA, NCR, Supplier Quality, and Document Management, ensuring compliance with industry standards and regulations.

Project Management: Lead and participate in global IT projects related to quality improvements, ensuring alignment with business goals and timelines.

Training & Documentation: Provide training and support for end users on IT systems and ensure proper documentation of processes.

Regulatory Compliance: Collaborate with regulatory teams to ensure IT solutions align with applicable regulatory requirements, particularly in the MedTech industry.

Continuous Improvement: Identify opportunities for process and system improvements in the Quality area, and lead initiatives to drive efficiency and effectiveness.

The Individual Bachelor's degree in Information Technology, Computer Science, Biomedical Engineering, or a related field.

Proven experience as an IT Specialist or Business Analyst, preferably in the MedTech industry.

Proven experience with SAP QM and IQVIA systems.

Familiarity with quality processes such as CAPA, NCR, Document Management, and Supplier Quality.

Strong knowledge of quality management systems and regulatory frameworks (ISO 13485, FDA 21 CFR Part 820, etc. ).

Exceptional communication skills in English, both written and verbal.

Willingness to travel up to 25%.

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