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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%.
Our commitment to Diversity & Inclusion: LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Notice to third party agencies: Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee.
Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment.
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