EU MDR/Mod Code Project Supply Chain Lead
The Supply Chain Project Leader will be a change agent that is fully accountable to deliver the EU MDR Supply Chain Project Objectives.
Accountability to complete EU MDR/Mod Code supply chain assessment for PLAN, MAKE, SOURCE and DELIVER for Vision Surgical to ensure E2E supply chain success for the implementation of EU MDR
Develop a project case to share all pertinent information as the supply chain leader reporting back to the EU MDR Program Leader on behalf of Supply Chain
Establish roles & responsibilities for all Supply Chain Core Team Members and extended team members as required throughout the project life cycle
Lead the supply core team through regular meetings and report back to the program leader on the following (but not limited to): Risks key challenges, Mitigation, Objectives, critical path tracking KPIS
Lead team to identify and manage risk throughout project
Manage relationship with program leader, sponsor, other core team members and supply chain steering committee, including regular reviews as required
Formally close Supply Chain portion of the project
Here are concrete work examples:
· Determine cut over plan for labeling in combination with RA for all products including identification of first MDR batch/serial number
· Product life cycle management discontinuation of products
· Barcode changes and implant card evaluation across Supply Chain
· Authorized rep for Tear Science
· Private label manufacturing
· Mod Code project
· Capacity planning tool
Experience and Key Competencies:
• Five (5) to eight (8) years of experience in any combination of the following related areas: Manufacturing, Quality, Supply Chain Planning, Engineering, Strategic Sourcing, and Distribution.
• Three (3) to five (5) years’ experience in Medical Device manufacturing is required.
• Proven high levels of effective communication skills, oral and written is required. Comfortable with virtual communications and with global attendees across multiple levels in the organization.
• Demonstrated strong project management skills, negotiation, financial, or analytical skills would be highly beneficial.
• Prior experience in large program and project management with people leadership skills
• Experience with Project Management/Six Sigma/Process Excellence tools, training and/or certification is preferred. • Self-starter / entrepreneurial / highly motivated Education
• A minimum of a Bachelor’s degree is required, preferably in Engineering, Supply Chain or Business.