Job Details

Business Process Analyst, PLM (Senior Quality Systems Specialist)

  2025-08-05     Katalyst Healthcares and Life Sciences     Santa Rosa,CA  
Description:

Job Description:
*Will be responsible for translating the current state ( "as-is ") business processes performed within our existing Product Lifecycle Management (PLM) system across various global design and manufacturing sites. You will then work closely with subject matter experts and the project team to document how these processes will be mapped and executed ( "to-be ") within the new Windchill PLM environment. Your work will be essential in creating clear documentation that bridges the gap between current operations and future state functionality, ensuring a smooth transition for end-users.
Responsibilities:

  • Collaborate with end-users, subject matter experts (SMEs), and project stakeholders across different functional areas (Engineering, Manufacturing, Quality, Regulatory) and site locations.
  • Support interviews, workshops, and reviews of existing documentation to thoroughly understand and translate current PLM-related business processes ( "as-is ") for approval. by customers and downstream consumption by the core design team and stakeholders.
  • Identify opportunities for consolidation of duplicative/overlapping documents and common processes, and support QMS Standardization efforts where needed.
  • Create clear, concise, and accurate process flow diagrams (using tools like Visio, Lucid chart, etc.) and narratives of current state operations.
  • Work with the implementation team and SMEs to understand the defined future state processes within Windchill.
  • Document the future state ( "to-be ") process flows, clearly illustrating how tasks currently performed in the legacy system will be accomplished in Windchill.
  • Map the relationships and transformations between "as-is " and "to-be " processes, highlighting key changes for users.
  • Support the development of training materials and communication plans by providing clear process documentation.
Requirements:
  • Bachelor's degree in business administration, Information Systems, Engineering, or a related field.
  • 2-5 years of experience in a Business Process Analyst, Process Analyst, or similar role involving process documentation and mapping.
  • Proven experience working with Product Lifecycle Management (PLM) systems.
  • Demonstrated proficiency in process mapping methodologies and tools (e.g., Visio, lucid chart, BPMN).
  • Direct hands-on experience with PTC Windchill PLM.
  • Experience working within a regulated industry (Medical Device, Pharmaceutical, Aerospace, Automotive) and familiarity with associated quality systems (e.g., QMS, ISO 13485, GxP).
  • Experience participating in large-scale system implementation projects (ERP, PLM, MES).
  • Familiarity with core PLM concepts such as Document Management, Change Management, Bill of Materials (BOM).


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