As a Business Systems Analyst specializing in QMS and PLM, you will play a critical role in ensuring the efficient operation and continuous improvement of our organization’s quality processes and product development lifecycle. You’ll collaborate with cross-functional teams, analyze business requirements, and drive system enhancements to optimize our QMS and PLM applications.
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Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position has the following responsibilities:
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QMS/PLM Analysis and Enhancement:
- Examine current QMS & PLM processes and identify opportunities to improve efficiency and compliance through system controls and automation.
- Collaborate with stakeholders to Analyze, develop, and communicate business and technical requirements for QMS & PLM systems.
- Participate in and lead kaizens to collaboratively deep dive into QMS & PLM performance. Identify and oversee implementation of continuous improvement opportunities in the respective IT Systems.
- Train end-users on new features and enhancements. Create communication and job aids to support adoption of new functionality.
- Establish strategic roadmap for QMS/PLM solutions aligned with ASP strategic initiatives
- Ensure alignment with regulatory standards (e.g., ISO 13485, 21CFR820, EU MDR, MDSAP).
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System Architecture and Development:
- Collaborate with development and support teams to design business solutions that leverage the simplest technical solution and intelligent architecture to minimize future debt and maximize re-usable components.
- Establish user stories, business cases, and acceptance criteria to translate and break down desired outcomes into functional layers a developer can bring to life.
- Establish development priorities for monthly sprints, perform technical and functional reviews of developed solutions, and oversee user acceptance testing to ensure solutions meet user needs and are validated for on time delivery.
- Develop and maintain test cases that ensure desired functionality is maintained and future enhancements don’t cause regression issues.
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Data Integration and Reporting:
- Integrate data from various sources into QMS and PLM systems.
- Generate regular management reports and dashboards on quality metrics.
- Support Quality, Regulatory, R&D, and Supply Chain staff in monitoring and improving products and processes.
- Responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed
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