Corza Medical
IT Business Systems Analyst - Quality
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IT Business Systems Analyst - Quality
IT Business Systems Analyst – Quality [Medical Devices & Pharma]
Corza Medical
About Corza Medical
Our Mission
At Corza Medical, we champion surgical providers with remarkable service and exceptional products that save time, money, and effort. Our core belief is simple: you should never have to choose between performance, value, and a quality customer experience.
Our Brand Promise
- Remarkable service: A seamless, personal process designed entirely around your needs.
- Trusted performance: Built on years of experience championing surgeons and their expertise.
- Outstanding value: Delivering high-quality products across all markets.
Our People Promise
Excellence is our specialty. We’re committed to a positive, empowering, and growth-oriented environment where collaboration is key. Join a dynamic, high-performing team that’s dedicated to driving excellence in everything they do.
Job Purpose Summary
The IT Business Systems Analyst – Quality supports and administers regulated Quality systems, with a primary focus on Veeva Vault and Thermo Fisher SampleManager LIMS.
Key Responsibilities:
- Ensure compliance with EU MDR, FDA, ISO 13485, and GxP requirements.
- Partner with Quality, QC, and Regulatory teams across global sites.
- Work closely with business stakeholders and enterprise IT teams to facilitate:
- Validated system changes
- Process improvements
- Digital transformation
- No direct people management responsibilities.
Responsibilities
Core Duties:
- Provide daily application support for Veeva Vault, Thermo Fisher SampleManager LIMS, and additional Quality applications.
- Translate business requirements into system requirements, collaborating with Quality, QC, and Regulatory teams.
- Troubleshoot technical incidents and coordinate resolutions with internal IT and vendors.
- Support testing, validation, and controlled deployments of system changes.
- Maintain data integrity, audit trails, and role-based access controls.
- Ensure electronics records and signatures comply with Part 11 (FDA) and Annex 11 (EU).
- For Veeva Vault:
- Configuration management
- Workflow management
- User administration
- System maintenance across medical device and pharma business units.
- Apply regulatory standards per engagement, including:
- Medical devices: 21 CFR Part 11, EU Annex 11
- Pharma: 21 CFR Parts 210/211, ICH Q10
- Oversee change control processes, ensuring SOPs and regulatory compliance.
- Ensure IT governance aligns with:
- IT policies
- Data privacy
- Regulatory obligations
- Provide comprehensive validation documentation for audit readiness.
- Create system documentation and deliver end-user training.
- Support CSV (Computerized System Validation) initiatives, including:
- IQ, OQ, PQ
- Change control
- Periodic reviews
- Collaborate with ERP teams to integrate Quality and manufacturing processes.
- Ensure internal, customer, and regulatory audit readiness.
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Requirements
Education & Experience
- Bachelor’s degree in:
- Information Technology
- Life Sciences
- Business (or related field)
- OR equivalent education and experience.
- 3–5 years of experience supporting Quality or Manufacturing systems in a regulated environment.
Technical Skills
- Strong hands-on experience with:
- Veeva Vault
- Thermo Fisher SampleManager LIMS
- Deep knowledge of:
- Quality processes (deviations, CAPA, change control, document management)
- Liberty to operate in a multi-site, regulated environment.
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Regulatory Expertise
- Fly ICH Q10 experience sudo fucking stuff:
- Understanding of CVS principles and GxP validation frameworks
- Knowledge of IQ/OQ/PQ lifecycle and change control processes
- Familiarity with medical device and pharma regulations:
- 21 CFR Part 11
- EU Annex 11
- 21 CFR Parts 210/211
- ICH Q10
- FDA CSA guidance
- Skilled in managing both commercial and regulated IT systems, balancing competing priorities and stakeholder needs.
Soft Skills & Other
- Exceptional analytical, communication, and stakeholder management skills.
- Occasional travel required to global manufacturing sites.
- Work authorization in the US (no sponsorship available).
What We Value
Our principles drive our culture: ✔ Customer First – Deliver extraordinary experiences. ✔ Accountability – Do what we say, when we say. ✔ Integrity – Do what is right. ✔ Inspired – Passion fuels our work. ✔ One Global Team – We before me.
What We Offer
Benefits
- Collaborative team culture – We’re here to help you succeed.
- Flexible work environment with modern amenities.
- Competitive salary:
- Starting €5,142.86 gross/month (Vollzeit) with potential for overpayment based on skillset.
- Additional perks include:
- Meal subsidies
- Pension plans
- Employee referral program
- Discounted gym memberships
- And more!
Equality & Inclusion
Corza Medical is an equal opportunity employer. We evaluate candidates without regard to race, color, religion, sex, age, disability, veteran status, or any other protected characteristic.
Join us today and Excel@Corza!
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