Quality Systems PLM Business Analyst (Hybrid - Acton, MA)

Insulet CorporationActon, MA
77d$72,000 - $108,000Hybrid

About The Position

The Quality Systems PLM Business Analyst will play a key role in supporting and enhancing Insulet's Product Lifecycle Management (PLM) systems. This individual will collaborate with cross-functional teams to gather business requirements, analyze workflows, and implement system improvements. The role includes light configuration of PLM tools, ongoing system maintenance, and user support to ensure optimal performance and compliance with quality standards.

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.

Nice To Haves

  • Experience with Arena PLM configuration and integration projects.
  • Exposure to data mapping and system integration (e.g., Arena to SAP).
  • Ability to manage multiple priorities and deliver in a fast-paced environment.
  • Experience in implementing or enhancing electronic PLM and/or EQMS systems.
  • Effective verbal and written communication skills.
  • Ability to communicate at multiple levels of an organization.
  • Ability to manage, organize tasks and judge priorities.

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.

Benefits

  • Base salary range of $72,000.00 - $108,000.00.
  • Hybrid working arrangements with on-site work from an Insulet office.

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What This Job Offers

Job Type

Full-time

Industry

Miscellaneous Manufacturing

Education Level

Bachelor's degree

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