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%

Job title

Quality Systems PLM Business Analyst

Job type

Experience level

Mid levelSenior

Salary

$72,000 - $108,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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