Overview
On Site
Full Time
Skills
Manufacturing
ISO 13485
Quality Management
Preventive Maintenance
Project Management
Performance Management
Regulatory Affairs
Marketing
Translation
Systems Engineering
ISO 9000
Regulatory Compliance
Leadership
Process Integration
Reporting
Training
QMS
Job Details
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.
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