Systems Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Skaneateles, NY 13152
Description:
Responsibilities:
Requirements:
- 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.