**Vacancy Name**
- Sr. Capas & Audit Veeva Super User
**Location of Work**
- Tijuana, Mexico
**Employment Type**
- Full Time Employee
**Job Purpose Summary**
Responsible for the development, implementation, and maintenance of Veeva System.
- Develop strategies and initiatives for maintaining the CAPA and Audit Quality Programs aligned with medical devices Regulations, Standards Requirements and Company goals and objectives.
- Primary responsibility is to maintain the activities related to CAPA and Audit Quality Programs. This position has knowledge and experience of working in regulated environments (i.e. ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and sufficient knowledge and experience using an electronic Quality system.
- **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_
- One Global Team: _We before me, always_
**What you will do (job duties)**
- Overall responsibility for supporting all activities related with Veeva System CAPA and Audit Modules.
- Training: Create and maintain training program by "Access Sub-Type" for New and Current Veeva Users
- Accesses: Supporting to obtain the New Accesses or changes in the "Access Sub-Type"
- Improvements: Participate in all projects related with Veeva updates of CAPA and Audit Modules.
- Maintain: Veeva System of CAPA and Audit Modules and Quality Metrics related.
- Create and Maintain yearly Internal Audit Program.
- Maintain and supporting External Audits (Customer, Notify Body, Inspections, etc.)
- Ensure the Company is prepared for internal, external and/or customer audits and inspections.
- Stablish and maintain an Internal Lead Auditor Certification program.
- Contributes to organizational change to create and sustain a work environment conducive to continuous improvement.
- Monitoring and maintain CAPA activities and Program.
- Support CAPA investigations as required.
- Mentor and train team members in Internal audits and CAPA programs
- Work on multiple projects simultaneously.
- Communicates effectively across teams to explain methodology, process, and results from analysis.
- Evaluate the accuracy and conformance to required procedures and performance improvement projects and initiatives.
- Leading CAPA Board Meetings
- Prepare quality documentation, metrics, and reports by collecting, analyzing and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions and re-validations.
- Schedule Management Review Meeting (s)
- Support to prepared Management Review presentation.
- Other duties as assigned.
**What you will need (job requirements)**
**Education**:Bachelor's Degree in a science, technical discipline or Experience equivalent.
- **Experience**:At least 5- 10 years of QMS and leadership experience in medical devices.
- **Languages**:Bilingual -** **Strong verbal and written communications skills.
- **Other Knowledge, Skills, Abilities or **Certifications**:
- Demonstrated experience working with diverse cultures.
- Strong organizational skills. Strong verbal and written communications skills.
- Demonstrated capability/experience raising issues and concerns and constructively challenging leadership to drive appropriate change and compliance.
- Management skills
- Effective communication
- Trainer skills
- Ability to establish and maintain effective interpersonal relationships at various levels of the organization.
- Experience with GMP, GDP, QMS, Audits, etc. as part of a Quality Culture.
**What you will like**
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.
- **Join our team.**
At Corza Medical, we are motivated by enabling our customers' success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and services that will ensure the continued success of our company and surgical professionals well into the future.
