IT Business Systems Analyst - Quality

IT Business Systems Analyst - Quality

Our mission

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience.

Job Purpose Summary

The IT Business Systems Analyst - Quality supports and administers regulated Quality systems, with primary responsibility for Veeva Vault and Thermo Fisher SampleManager LIMS. The role ensures systems remain compliant with EU MDR, FDA, ISO 13485, and GxP expectations, while supporting quality, QC and regulatory across multiple global sites.

The role partners closely with business stakeholders and enterprise IT teams to support validated system changes, continuous improvement initiatives, and digital transformation efforts, without direct people-management responsibility.

What you will do

• Provide day-to-day application support for Veeva Vault and Thermo Fisher SampleManager LIMS, and/or any additional quality applications.
• Partner with Quality, QC, and Regulatory teams to translate business processes into system requirements.
• Troubleshoot incidents and coordinate resolution with internal IT teams and vendors.
• Support testing, validation, and controlled deployment of system changes.
• Ensure data integrity, audit trails, and role-based access controls across Quality systems.
• Collaborate with ERP teams to support end-to-end Quality and manufacturing processes.
• Create system documentation and deliver end-user training.
• Support CSV activities including IQ/OQ/PQ, change control, and periodic review.
• Maintain inspection readiness and support internal, customer, and regulatory audits.
• Ensure electronic records and signatures meet Part 11 and Annex 11 requirements.
• Administer Veeva Vault QMS, including configuration, workflow management, user administration, and system maintenance in support of quality operations across medical device and pharmaceutical business units.
• Apply regulatory frameworks including 21 CFR Part 11, EU Annex 11, 21 CFR Parts 210/211, and ICH Q10.
• Manage change control processes for validated systems, including impact assessments, testing coordination, and documentation.
• Partner with Quality, Regulatory, and IT stakeholders across business units to ensure computerized systems meet applicable GxP and cGMP requirements.

What you will need

• Bachelor's degree in Information Technology, Life Sciences, Business, or a related field; or equivalent education and work experience.
• 3-5 years experience supporting Quality or Manufacturing systems in a regulated environment.
• Strong hands-on experience with Veeva Vault and Thermo Fisher SampleManager LIMS.
• Understanding of Quality processes including deviations, CAPA, change control, and document management.
• Ability to work in a regulated, multi-site environment.
• Strong analytical, communication, and stakeholder management skills.
• Strong working knowledge of CSV principles and GxP validation frameworks, including IQ/OQ/PQ lifecycle and change control for validated systems.
• Familiarity with FDA Computer Software Assurance guidance and its application to validation strategy.
• Occasional travel may be required to global manufacturing sites.

What we value

• Customer First - We deliver extraordinary experiences.
• Accountability - We do what we say.
• Integrity - We do what is right.
• Inspired - We love what we do.