Supplier Quality Engineer

Katalyst CRO; Raynham (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an experienced Supply Chain Program Manager / Supplier Quality Engineer to lead global supply chain initiatives for NPI, supplier transfers, and readiness in a regulated manufacturing environment.

The ideal candidate has deep expertise in supplier quality, project leadership, and cross‑functional collaboration across supply chain, operations, manufacturing, engineering and quality, with hands‑on experience in FDA-regulated settings.

Qualifications

• Bachelor's degree in supply chain, industrial engineering, manufacturing engineering, or related field.
• 5+ years of experience in Supply Chain Program Management, Supplier Quality Engineering, or regulated supply chain roles.
• Experience in FDA-regulated or highly regulated manufacturing environments preferred.

Responsibilities

• Lead and execute global supply chain initiatives including NPI and product launches.
• Coordinate supplier qualification, onboarding, sourcing, and deployment activities.
• Drive supplier performance, readiness, and collaboration for launches and transfers.
• Facilitate cross-functional leadership across Supply Chain, Operations, Manufacturing, Engineering, and Quality.

Skills

Supply Chain Management

Supplier Quality Engineering

New Product Introduction

Supplier Transfers & Deployment Readin

Cross-Functional Project Leadership

Change Management

Education

Bachelor's Degree in a related field

Tools

ERP systems

PLM systems

S&OP/IBP

Job description

Job Summary

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.

Roles & Responsibilities

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.

Supplier Management & Supplier Quality

• 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.

Cross-Functional Leadership

• 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.

Supply Planning & Operational Readiness

• 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.

Change Management & Systems Readiness

• 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.

Stakeholder Communication & Governance

• 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.

Education & Experience

• 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.