What are the responsibilities and job description for the Supplier Quality Engineer position at Katalyst CRO?
Job Summary
Supply Chain Program Leadership
- We are seeking an experienced Supply Chain Program Manager / Supplier Quality Engineer to lead global supply chain initiatives supporting new product introductions (NPI), supplier transfers, sourcing programs, and supply chain readiness activities within a regulated manufacturing environment.
- The ideal candidate will possess strong expertise in supply chain operations, supplier quality, project management, and cross-functional leadership, preferably within Medical Device, Pharmaceutical, or Life Sciences industries.
- This role will drive execution across sourcing, qualification, deployment, and operational readiness while ensuring compliance with quality and regulatory standards.
Supply Chain Program Leadership
- Lead and execute global supply chain initiatives including:
- New Product Introductions (NPI)
- Product market releases
- Supplier transfers and transitions
- Supply chain readiness programs
- Develop and manage project plans, timelines, milestones, and risk mitigation strategies.
- Drive tactical execution to ensure alignment with business and operational objectives.
- Collaborate with domestic and international suppliers to support successful project execution and launch readiness.
- Coordinate supplier qualification, onboarding, sourcing, and deployment activities.
- Support supplier quality initiatives and ensure compliance within regulated manufacturing environments.
- Drive supplier performance, readiness, and collaboration for product launches and transfers.
- Lead cross-functional collaboration across:
- Supply Chain
- Operations
- Manufacturing
- Engineering
- Quality
- External Suppliers
- Facilitate meetings, track action items, manage dependencies, and resolve execution risks.
- Ensure accountability and alignment across stakeholders throughout the project lifecycle.
- Support demand planning, supply planning, and deployment readiness initiatives.
- Participate in sourcing, qualification, and launch readiness activities.
- Ensure compliance with supply chain governance standards and readiness processes.
- Support S&OP / Integrated Business Planning (IBP) activities and operational planning processes.
- Manage operational change activities associated with:
- ERP systems
- PLM systems
- Manufacturing changes
- Product introductions and transfers
- Support system setup, deployment readiness, and process implementation activities.
- Drive change management initiatives within regulated operational environments.
- Communicate project status, risks, and readiness updates to leadership and key stakeholders.
- Present program progress and escalation items across organizational levels.
- Monitor execution to ensure alignment with business goals, timelines, and compliance requirements.
- Bachelor's Degree in Supply Chain Management, Industrial Engineering, Manufacturing Engineering, Business Operations, Life Sciences, or related field.
- Minimum 5 years of experience in Supply Chain Program Management, Supplier Quality Engineering, or Supply Chain Operations within Medical Device, Pharmaceutical, Life Sciences, or other regulated industries.
- Strong experience with:
- Supplier Quality & Supplier Qualification
- Supply Chain Management
- New Product Introduction (NPI)
- Supplier Transfers & Deployment Readiness
- Manufacturing Supply Chain Operations
- Change Management
- Cross-Functional Project Leadership
- Working knowledge of:
- ERP systems
- PLM systems
- S&OP / Integrated Business Planning (IBP)
- Regulated manufacturing and quality systems
- Experience working in FDA-regulated or highly regulated manufacturing environments preferred.
- Strong communication, stakeholder management, and problem-solving skills.