Supply Chain Specialist

The Supply Chain Specialist is responsible for purchasing materials, components, and services while coordinating all inbound and outbound logistics for a regulated manufacturing operation. This role ensures timely availability of critical supplies used in the production of medical devices, supporting both efficiency and compliance with applicable quality and regulatory standards.

Key Responsibilities

Purchasing & Supplier Management

• Source, evaluate, and procure raw materials, components, and services required for manufacturing (e.g., biomaterials, polymers, catheter components, sterile packaging).
• Develop and maintain relationships with approved suppliers to ensure consistent quality, cost-effectiveness, and reliability.
• Issue and manage purchase orders, tracking delivery status to ensure on-time fulfillment.
• Negotiate pricing, lead times, and supply agreements to support organizational objectives.
• Partner with Quality and Regulatory teams to ensure supplier adherence to applicable standards (e.g., ISO standards, FDA regulations).
• Support supplier qualification processes, audits, and ongoing performance assessments.

Inventory & Materials Management

• Monitor inventory levels to maintain appropriate stock of critical materials without risk of overstocking.
• Work closely with production planning to align procurement with manufacturing schedules.
• Utilize ERP/MRP systems for material planning, demand forecasting, and order tracking.
• Identify, assess, and mitigate risks related to material shortages or supply chain interruptions.

Logistics & Distribution

• Coordinate domestic and international shipments, including temperature‑controlled medical device shipments.
• Ensure compliance with import/export regulations and all required documentation.
• Maintain relationships with freight carriers and logistics partners.
• Optimize transportation costs while safeguarding delivery timelines and product integrity.
• Oversee receiving processes and warehouse organization.

Compliance & Quality

• Ensure all purchasing, inventory, and logistics processes comply with internal quality systems and regulatory requirements.
• Maintain accurate, complete documentation to ensure material traceability.
• Support internal, external, and regulatory audits as needed.
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Required Qualifications

• Bachelor's degree in Supply Chain Management, Business, Engineering, or a related field.
• 2-5+ years of experience in purchasing, logistics, or supply chain, ideally within medical device, biotech, or other regulated manufacturing sectors.
• Experience with ERP/MRP systems (e.g., SAP, Oracle, or equivalent).
• Knowledge of FDA regulations, ISO 13485, and GMP strongly preferred.
• Strong negotiation, analytical, and organizational capabilities.
• Proficiency in Microsoft Excel and supply chain management tools.

Preferred Qualifications

• Experience handling implantable medical devices or sterile production environments.
• Familiarity with customs and international shipping practices.
• Professional certifications such as APICS/ASCM CPIM.

Key Competencies

• High attention to detail, especially regarding compliance and traceability.
• Strong problem‑solving and risk‑management skills.
• Ability to collaborate effectively with cross‑functional teams (engineering, quality, manufacturing).
• Excellent time management with the ability to prioritize in a fast‑paced environment.
• Clear communication skills for engaging both internal teams and external suppliers.

Work Environment

• Combination of office setting and manufacturing floor presence.
• May require interactions with cleanroom operations and adherence to gowning protocols.
• Occasional travel for supplier visits or audits.