Quality Systems PLM Business Analyst supporting and enhancing Insulet’s Product Lifecycle Management systems. Working with cross-functional teams to gather requirements, implement improvements, and support system performance.
Responsibilities
Partner with business stakeholders to identify and document PLM enhancement opportunities.
Translate business needs into functional requirements and user stories for PLM system improvements.
Perform light configuration and setup within Arena PLM or other platforms, including workflows, fields, and user roles.
Support PLM system maintenance activities such as user provisioning, data integrity checks, and release testing.
Assist in the validation of PLM system changes, including test script development and execution.
Monitor system performance and user feedback to identify areas for continuous improvement.
Collaborate with IT and Quality teams to ensure PLM changes align with QMS and regulatory requirements.
Participate in cross-functional meetings and projects related to PLM, document control, and change management.
Maintain documentation related to PLM configurations, enhancements, and training materials.
Requirements
Typically requires a four-year degree from an accredited University or a combination of education and relevant work experience.
3+ years of experience in PLM systems (Arena, Oracle Cloud, Agile, etc.) within a regulated industry.
Strong understanding of Quality Management Systems (QMS), including change control and document control processes.
Experience with system configuration, user support, and business analysis in a PLM environment.
Familiarity with GxP, ISO 13485, 21 CFR Part 820, and other relevant standards.
Excellent communication and collaboration skills across technical and non-technical teams.
Proficiency in Microsoft Office and experience with tools like Jira, ServiceNow, or similar platforms is a plus.
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