Corza Medical
IT Business Systems Analyst - Quality
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IT Business Systems Analyst - Quality
IT Business Systems Analyst – Quality
About the Role
In line with our mission to champion surgical providers through exceptional service and product innovation, Corza Medical is seeking an experienced IT Business Systems Analyst – Quality to support and administer regulated Quality systems, with a primary focus on Veeva Vault and Thermo Fisher SampleManager LIMS.
As part of our mission, this role ensures systems remain compliant with:
- EU MDR
- FDA
- ISO 13485
- GxP expectations
You’ll collaborate closely across Quality, QC, Regulatory teams, support validated system changes, contribute to continuous improvement, and digital transformation, while working alongside enterprise IT teams.
Job Purpose Summary
The IT Business Systems Analyst – Quality is responsible for:
- Supporting Veeva Vault and Thermo Fisher SampleManager LIMS
- Ensuring compliance with international regulatory frameworks across multiple global sites
- Partnering with stakeholders to translate business processes into system requirements
- Without direct management responsibility for people
What You Will Do
- Provide day-to-day technical and application support for Veeva Vault, SampleManager LIMS, and other quality systems.
- Partner with Quality, QC, and Regulatory teams to define system requirements based on business needs.
- Troubleshoot incidents and coordinate with internal IT teams and vendors for resolution.
- Validation support, including testing, execution, and controlled deployment of system changes in compliance with IQ/OQ/PQ standards.
- Ensure data integrity, user access (RBAC), and audit trails within regulated systems.
- Collaborate with ERP teams to streamline Quality and manufacturing workflows.
- Develop and update system documentation, as well as provide tailored training.
- Manage CSV activities, including:
- Change control processes
- Periodic reviews
- Corrected Action Preventive Action (CAPA) implementation
- Maintain audit readiness for internal, customer, and regulatory evaluations.
- Ensure compliance with Part 11 and Annex 11 certifications for affecting records.
- Administer Veeva Vault QMS, including:
- Configuration
- Workflow management
- User administration
- System maintenance
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Regulatory & Validation Focus
- Ensure compliance with the appropriate regulatory framework:
- Medical devices: 21 CFR Part 11, EU Annex 11
- Pharmaceutical systems: 21 CFR Parts 210/211, ICH Q10
- Manage change control processes, including:
- Impact assessments
- Testing coordination
- Drafting compliant documentation
- Partner with stakeholders across multiple business units to align systems with GxP and cGMP requirements.
- Help shape data privacy and IT governance policies, ensuring alignment with both technical and regulatory standards.
What You Will Need
Education
- Bachelor’s degree in Information Technology, Life Sciences, Business, or related field (or equivalent experience and training).
Experience & Skills
- 3–5 years direct experience supporting regulated quality or manufacturing systems.
- Strong working knowledge of Veeva Vault and Thermo Fisher SampleManager LIMS and their applications.
- Understanding of key Quality processes including:
- Deviations
- CAPA
- Change control
- Document management
- Ability to work confidently in a multi-site, regulated environment with varying priorities.
- Analytical, communication, and stakeholder engagement skills.
- Comprehensive understanding of CSV and GxP validation frameworks, including:
- IQ/OQ/PQ lifecycle management for validated systems
- Change control compliance
- Demonstrated knowledge of:
- Medical device and pharmaceutical regulations: 21 CFR Part 11, EU Annex 11, 21 CFR Parts 210/211, ICH Q10.
- FDA Computer Software Assurance (CSA) guidance and its relevance to validation strategies.
- Experience in integrating commercial and regulated IT workflows to balance competing strategies and stakeholder expectations.
- Ability to engage effectively with technical, business, regulatory, and quality teams.
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Travel & Eligibility
- Occasional travel may be required to global manufacturing sites.
- Eligibility: Applicants must be authorized to work in the United States. Corza cannot sponsor visas or immigration status at this time.
What We Value at Corza
We champions a culture where our most valued principles include:
- Customer First – Delivering extraordinary experiences to partners, users, and stakeholders.
- Accountability – Consistent delivery on promises and commitments.
- Integrity – Making decisions that reflect what’s right and ethical.
- Inspired – Taking pride in what we do and passionate about contributing value.
- One Global Team – Teamwork and collaboration above individual focus, with "We over Me".
Benefits at Corza Medical
For You and Your Performance
- Scalable full-time brutto monthly salary starting at €5.142.86, with potential for performance-based increments.
- Diverse projects with responsibility and professional growth.
- Flexible work environment and work-life balance.
Perks and Support
- Meal allowance
- Corporate retirement plan (pension/Altersvorsorge)
- Employee referral program
- Subsidized gym membership
Join Corza Medical today to Excel@Corza!
Corza Medical’s Inclusive Approach
We are an equal opportunity employer. Our values do not tolerate discrimination:
- Race
- Color
- Marital status
- Religion
- Sex
- Sexual orientation
- Gender identity
- Age
- National origin
- Physical/mental disability
- Veteran status, or any other protected characteristic
Everyone’s contributions matter.
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