Quality Management System, Senior Business Analyst
Quality Management System, Senior Business Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position
The EQMS Business Analyst will be responsible for identifying developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. The individual will also be accountable for managing projects and software throughout their respective lifecycles with a focus on supporting the transition from Trackwise On-Premise to Trackwise Digital in Salesforce Cloud and maintaining the Veeva Regulatory Information Management (RIM) solution.
Essential Job Duties
- Participate in the analysis configuration modification and implementation of IT Business Systems specifically Trackwise and Veeva RIM.
- Demonstrate strong communication analytical and problem-solving skills to help identify communicate and resolve system issues to maximize the benefit of IT systems.
- Analyze the effectiveness and efficiency of existing business processes and business requests recommending solutions using system standards and best practices.
- Conduct analysis of system specifications configurations and develop appropriate documentation.
- Create detailed specifications and process flows to provide direction to application developers.
- Perform solution designing requirements definition functional design testing and implementation of IT solutions with a focus on transitioning to Trackwise Digital.
- Support assist and train users on new and modified system configurations highlighting the impact on business processes.
- Maintain IT Business system integrity application notes system upgrades changes and user updates.
- Collaborate closely with onsite and offshore teams managers and executives to ensure the release of high-quality solutions.
- Comply with regulatory and change control requirements and processes.
Qualifications :
Required Skills and Experience
- Minimum 5 years of experience in Trackwise System Analysis.
- Experience with Trackwise Digital and its integration with Salesforce Cloud.
- Proficiency in Veeva RIM solution management.
- Experience in the Medical Device manufacturing industry and systems regulations (21 CFR Part 11 GxP GAMP) with a good understanding of CAPA and Complaints processes.
- Experience in business requirements gathering requirements analysis business system design installation configuration user testing and validation support of Trackwise and Veeva RIM applications.
- Java Programming: Strong knowledge and experience in Java programming including Java 8 features and beyond.
- Frameworks: Proficiency in Java frameworks such as Spring Hibernate and Apache Struts for building and maintaining applications.
- Web Technologies: Understanding of web technologies like HTML CSS and JavaScript with frameworks like Angular or React.
- Database Management: Experience with database management systems (DBMS) like MySQL Oracle or MongoDB including SQL queries and database design.
- Experience in creating workflows business rules TWC automation notifications and migration updates.
- Experience with creating Trackwise WebServices (Search/Populate/Transfer) using OWS/IWS.
- Experience in creating and implementing Crystal Reports.
- Exposure to integration with SAP ERP and CRM systems is preferred.
- Familiarity with Software Development Lifecycle (SDLC) processes.
- Excellent verbal and written communication skills.
- Ability to work on multiple projects concurrently.
- Ability to work with minimal supervision or guidance.
- Contribution to team building measures like Knowledge Management & Mentoring.
Required Education and Training
- Minimum education: Bachelors or undergraduate degree in Computer Science Information Systems or equivalent experience.
Working Conditions
- None
Preferred Skills and Experience
- Experience with Trackwise & Trackwise Digital is preferred.
- Experience with Veeva RIM solution is highly desirable
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
