Procurement Specialist, EU MDR

The Procurement Specialist - MDR will support the Procurement and Sourcing organizations to prepare our outsourced processes and suppliers for the EU Medical Device Regulation (MDR). They will be a part of a larger EU MDR project team and own all supplier related actions, communications, and projects for the EI MDR project.

Responsibilities:

• Establish and maintain strong relationships with suppliers to foster collaboration and ensure effective communication for EU MDR.
• Identification, evaluation, mitigation of suppliers to meet EU MDR requirements.
• Serve as the primary point of contact for suppliers in the context of the EU MDR project.
• Prepare and issue Requests for Quotation (RFQs) to potential suppliers in the context of EU testing and sampling.
• Work with suppliers on labeling, specifications, manufacturing process flows, 2D bar coding, Inspection plans, Drawings, Process Risks, Equipment, and capability, Validations, etc.
• MDR sampling, testing, or if product transfers are needed to maintain security of supply.
• Collaborate with internal stakeholders and suppliers to resolve problems and ensure timely solutions.
• If needed, support product transfers by coordinating internally and externally to ensure a smooth transition.
• Work with suppliers to resolve any drawing-related issues.
• Manage ERP to match ASL and EU MDR approval status.

Qualifications:

• Bachelor's degree in Supply Chain Management, Business, Finance, Engineering, or related field required.
• 4 years engineering or supply chain management supporting new product introductions required.
• Medical Device, Pharmaceutical, or other highly regulated industry experience highly preferred.
• Experience in a manufacturing environment preferred.
• Stakeholder management and ability to influence suppliers, peers, and leadership required.
• Ability to negotiate effectively to obtain best prices and terms on products, materials, and services required.
• Ability to recognize risks and propose and develop contingency plans required.
• Ability to effectively communicate and collaborate within all levels of the organization required.
• Strong analytical skills, ability to plan, organize, and implement multiple concurrent tasks required.
• PC literate and proficient in MS Office 365 and Excel analytics and reports required.
• Proficient in delivering results required.
• Good business & financial acumen is preferred.
• Experience in JDE preferred.
• Basic Med Device EU MDR knowledge.

Salary : $37 - $42