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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. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. 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. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Beware of Job Scams:
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. 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. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.
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