What you'll be doing:
- Work closely with Quality and Manufacturing Engineering to support the process of developing and qualifying suppliers, and disqualification of suppliers as required
- Develop the processes for establishing and managing supplier relationships
- Work with Legal to implement contracts (Material Supplier Agreements) for all suppliers to mitigate risk to business operations
- Lead contract negotiations to ensure long term cost reduction and strategic partnerships with suppliers
- Work with Engineering in identifying new supply sources and evaluating vendor reliability
- Direct the company demand planning process, including strategic demand planning initiatives, Master Production Schedules, and Material requirements planning process. Leads the Operation's team in support of the Sales, Inventory, and Operations Planning process
- Responsible for all purchasing controls and ensures compliance to all regulatory requirements, including FDA, ISO 13485, SEC requirements (conflict minerals), and Sarbanes Oxley controls
- Manage the organization responsible for the purchasing process, including obtaining quotations and placing purchase orders from qualified suppliers for goods and services utilized in the manufacturing of medical products
- Manage the organization responsible for demand planning across all product families and develops short term supply mitigation solutions in response to sudden demand changes or product quality issues
- Manage the organization responsible for MRO buying (Maintenance, Repair, and Operating supplies)
- Organizational responsibilities for establishing International business processes such as planning and distribution, including relationship with International Distributors.
- Manage the organization responsible for material inventory and distribution including the processes for Inventory Management Reporting, including ADOH (average days on hand) and develops applicable metrics for evaluation and control of purchased material.
- Manage the organization responsible for the infusion set products including procurement, inventory control, distribution and business relationship.
- Work with Manufacturing Engineering and Quality to develop and implement component and supplier cost reduction strategies to achieve business results by lowering overall product costs
- Provide support for new product introductions into manufacturing
- Ensure department's adherence to company policies, including Privacy/HIPAA, as well as other legal and regulatory directives.
- Direct long and short-term planning for the department including headcount, budgeting, training, and systems requirements.
- Participate in the selection, development, performance appraisal, merit recommendation, and promotion of department staff.
- Support the development, communication, and evaluation of goals for the group based on company goals on an annual basis.
- Other duties as assigned.
What you need for this position:
- Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
- Extensive knowledge of ERP systems for planning, scheduling, purchasing and inventory
- Proven ability to drive quality and productivity improvements.
- Excellent skills in cGMP documentation, policies and procedures, protocols, work instructions, inspection requirements, etc.
- Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
- Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
- Ability to provide annual organizational budget requirements such as resources and materials
Minimum certifications/educational level:
- BA/BS or equivalent combination of education and applicable job experience.
- APICS certification preferred.
- 15 years experience in supply chain management within a $500M medical device market.
- Experience in planning, scheduling, and monitoring the movement of materials through the production cycle and in providing procurement support to new product programs.
- cGMP experience.