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Position Title: Senior Buyer
Work Location: Pleasanton, CA 94588, USA
Assignment Duration: 4+ months
Work Arrangement: Onsite Position Summary:
The Senior Buyer is responsible for strategic sourcing, procurement, supplier management, and inventory planning in support of medical device manufacturing operations. This position plays a critical role in ensuring the timely availability of materials, components, and services while maintaining compliance with FDA, ISO 13485, and company quality requirements. Background & Context:
The Senior Buyer partners closely with Manufacturing, Engineering, Quality, Regulatory Affairs, and Finance to support production schedules, new product introductions, and continuous improvement initiatives. Key Responsibilities:
- Manage procurement activities for direct materials, components, assemblies, and indirect goods/services supporting medical device manufacturing.
- Develop and execute sourcing strategies that optimize cost, quality, delivery, and supplier performance.
- Negotiate pricing, contracts, long-term agreements, and supplier terms and conditions.
- Create, issue, and manage purchase orders through ERP/MRP systems.
- Monitor supplier delivery performance and proactively address supply chain risks or shortages.
- Partner with Supplier Quality and Regulatory teams to ensure suppliers meet FDA, ISO 13485, GMP, and internal quality requirements.
- Support supplier qualification, onboarding, audits, and corrective action activities.
- Collaborate with Engineering and Operations teams to support New Product Introduction (NPI), product transfers, and design changes.
- Analyze demand forecasts, inventory levels, and production requirements to maintain material availability while minimizing excess inventory.
- Lead supplier performance reviews and drive continuous improvement initiatives.
- Identify alternate sources of supply and develop risk mitigation strategies for critical components.
- Support cost-reduction initiatives through supplier negotiations, value engineering, and strategic sourcing activities.
- Maintain procurement records and ensure compliance with company policies and regulatory requirements.
Qualification & Experience:
- Bachelor's degree in Supply Chain Management, Business Administration, Engineering, Operations Management, or a related field.
- 5+ years of purchasing, sourcing, or procurement experience within a medical device, biotechnology, pharmaceutical, or regulated manufacturing environment or other.
- Experience managing direct materials and contract manufacturers.
- Strong understanding of FDA-regulated manufacturing environments and supplier quality requirements.
- Experience with ERP/MRP systems such as Oracle, SAP, NetSuite, or JD Edwards.
- Advanced Microsoft Excel skills, including data analysis and reporting.
- Excellent negotiation, communication, and supplier relationship management skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Experience supporting Class II or Class III medical device manufacturing.
- Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and supplier quality systems.
- Professional certifications such as CPSM, CPM, CSCP, or APICS certifications.
- Experience with international sourcing and global supplier management.
- Experience supporting contract manufacturing organizations (CMOs) and contract manufacturers.
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