Purchase Head - Medical Devices

Job Purpose:

To lead the procurement function for raw materials, reagents, packaging materials, capital goods, and services for the IVD manufacturing unit, ensuring cost-effective and timely procurement in compliance with regulatory requirements such as CDSCO, ISO13485, and other applicable standards.

Key Responsibilities:

Strategic Sourcing Procurement:

- Develop and implement procurement strategies for critical IVD components like enzymes, antibodies, plastic consumables, and packaging materials.

- Identify and qualify vendors in India and internationally, including due diligence in line with regulatory standards.

- Negotiate contracts and terms with suppliers to ensure optimal cost,quality,and lead times.

- Ensure procurement aligns with ISO 13485 and Good Manufacturing Practices (GMP) requirements.

Vendor Management:

- Build and maintain strong relationships with approved vendors and strategic partners.

- Monitor vendor performance through audits,delivery performance,quality checks,and pricingconsistency.

- Ensure alternate sourcing for all critical raw materials to avoid stockouts.

Compliance s Documentation:

- Ensure all purchase documentation is audit-ready for CDSCO, USFDA (if applicable), ISO 13485, etc.

- Maintain Purchase Orders, vendor qualification documents, certificates of analysis (CoAs), and MSDS for all critical supplies.

- Coordinate with QA/QC to ensure incoming material meets quality specs.

Cost Management:

- Monitor procurement budgets and drive cost-saving initiatives without compromising quality.

- Evaluate total landed cost (TLC) including customs duties, freight, and taxes for imports.

Inventory Coordination:

- Work closely with production and warehouse teams to forecast material requirements.

- Maintain optimal stock levels using inventory management systems like SAP /ERP.

Cross-Functional Collaboration:

- Coordinate with RCD for procurement of lab-scale materials and pilot production needs.

- Support regulatory and RA teams for submissions requiring vendor data or material specs.

- Collaborate with legal for vendor agreements and contracts.

Qualifications:

- Bachelor's degree in Science /Engineering; MBA in Supply Chain/Operations preferred.

- Minimum10-15 years of experience in procurement, preferably inIVD,pharma,ormedical devices.

- Hands-on experience with ISO 13485,GMP,CDSCO, and import/export regulations.