Systems Engineer - Katalyst Healthcares and Life Sciences : Job Details

Systems Engineer

Katalyst Healthcares and Life Sciences

Job Location : Skaneateles,NY, USA

Posted on : 2025-08-05T07:51:58Z

Job Description :
Responsibilities:
  • Responsible for integration of design and manufacturing process procedures, templates and guidance documents within an ISO 13485 compliant Quality Management System (QMS).
  • Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.).
  • Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs.
  • Demonstrated understanding of Systems Engineering driven process for achieving ISO 14971 compliance. Preferred QMS process owner work history.
Requirements:
  • Work with FLC Leadership team to define and scope QMS integration goals.
  • Review selected target QMS procedures & propose local redlines to enable conflict free process integration.
  • Drive stakeholder reviews/approvals & route for release.
  • Report periodic integration status to stakeholders.
  • Participation in 'deep dive' reviews of selected procedures with SMEs.
  • daptation of adopted training material for target QMS to accommodate redlines.
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