Provide Tier 1 application support for our end - users and clients in a demanding environment. Support onsite and remotely as part of the Enterprise Technologies team.
About the role
- 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.
Benefits
- Hybrid working arrangements
- Domestic and International travel up to 10%
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