RequirementsPosition SummaryThe Procurement Manager is responsible for developing and executing sourcing strategies, managing supplier relationships, negotiating commercial agreements, and ensuring uninterrupted supply of materials required for research, manufacturing, and commercialization of IVD products. The successful candidate will work cross-functionally with Operations, Manufacturing, R&D, Quality, Regulatory Affairs, Finance, and Logistics to optimize procurement performance while maintaining compliance with FDA and ISO 13485 requirements.
Key ResponsibilitiesStrategic Sourcing- Develop and execute procurement strategies aligned with business objectives.
- Source and qualify suppliers for critical raw materials, biological reagents, chemicals, consumables, packaging materials, and manufacturing components.
- Identify alternative suppliers and develop dual-source strategies to mitigate supply risks.
- Monitor supplier markets, industry trends, and pricing to improve sourcing decisions.
Supplier Relationship Management- Establish and maintain strong partnerships with domestic and international suppliers.
- Lead supplier selection, qualification, performance evaluations, and business reviews.
- Collaborate with Quality and Regulatory teams on supplier audits and corrective actions.
- Drive continuous supplier performance improvement in quality, delivery, service, and cost.
Procurement Operations- Manage purchasing activities to ensure timely delivery of materials supporting manufacturing and R&D.
- Negotiate pricing, contracts, payment terms, and service agreements.
- Monitor inventory levels and collaborate with planning teams to maintain optimal stock levels.
- Resolve supply disruptions and develop contingency plans for critical materials.
Cost Management- Identify and implement cost reduction initiatives without compromising quality or regulatory compliance.
- Analyze spend data and procurement metrics to improve purchasing efficiency.
- Support annual budgeting and forecasting activities.
Cross-Functional Collaboration- Partner with Manufacturing, R&D, Quality Assurance, Regulatory Affairs, and Finance to support new product introductions and product lifecycle management.
- Support supplier qualification and material validation for new products.
- Participate in design transfer and commercialization projects.
Compliance & Documentation- Ensure procurement activities comply with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, company policies, and applicable regulations.
- Maintain procurement documentation, supplier records, contracts, and purchasing procedures.
- Support internal and external quality audits.
QualificationsRequired- Bachelor's degree in Supply Chain Management, Business, Engineering, Life Sciences, or a related field.
- 5+ years of procurement or strategic sourcing experience, with at least 3 years in the medical device, diagnostics, biotechnology, pharmaceutical, or life sciences industry.
- Experience negotiating supplier agreements and managing supplier relationships.
- Strong analytical, negotiation, and problem-solving skills.
- Excellent verbal and written communication skills.
- Proficiency with ERP/MRP systems (SAP, Oracle, NetSuite, Microsoft Dynamics, or similar).
- Advanced Microsoft Excel skills.
Preferred Fluent in both Chinese and English
- Experience in the In Vitro Diagnostics (IVD) industry.
- Familiarity with biological reagents, antibodies, antigens, enzymes, chemicals, plastics, instrumentation components, or laboratory consumables.
- Knowledge of FDA regulations, ISO 13485, GMP, and supplier quality management.
- Experience with global sourcing and international suppliers.
- APICS (ASCM), CPSM, or CPM certification is a plus.
- Ability to travel up to 20% as needed.
Key Competencies- Strategic Sourcing
- Supplier Relationship Management
- Contract Negotiation
- Cost Reduction & Spend Analysis
- Risk Management
- Supply Chain Planning
- Cross-Functional Leadership
- Project Management
- Data Analysis & Decision Making
- Continuous Improvement
Success Metrics- Supplier On-Time Delivery (OTD)
- Cost Savings Achievement
- Supplier Quality Performance
- Inventory Optimization
- Procurement Lead Time
- Supplier Risk Reduction
- Material Availability for Production
- Procurement Process Efficiency
BenefitsWhat We Offer- Competitive salary and annual performance bonus
- Comprehensive medical, dental, and vision insurance
- 401(k) with company match
- Paid Time Off (PTO) and company holidays
- Professional development and career growth opportunities
- Collaborative and mission-driven work environment
