Job Summary: 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 be the owner for all supplier related actions, communications, and projects for the EI MDR project. Responsibilities:
Establish and maintain strong relationship 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 context of the EU MDR project
Prepare and issue Requests for Quotation (RFQs) to potential suppliers in 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.
Work collaboratively 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:
Bachelors 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
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.