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Localisation: Salt Lake City, UT, États-Unis
Type de Contrat: Unfixed Term
The Supplier Program Specialist is responsible for the supplier management activities at the bioMerieux Salt Lake City’s Purchasing Department. These program responsibilities include but are not limited to the following: supplier quality performance reviews through vendor score cards; supplier selection and onboarding; and trend analysis on both supplier and individual part quality performances. In addition, this role will contribute in leading regular supplier review board and material review board meetings to ensure that we are effectively managing our suppliers in meeting their quality and contractual obligations to the business. This position will be responsible to maintain, create, and update appropriate supplier documents such as the Supplier Checklist, Supplier Surveys, NDA’s, Strategic Agreements, and other applicable supplier documents for suppliers on the Approved Supplier List (ASL). The Supplier Program Specialist will also work with Quality Assurance in maintaining the Approved Supplier List.
This position will be instrumental in all BSI, FDA, IVDR, MDSAP, and internal audits to ensure the company is managing their suppliers to be compliant based on needed requirements. Other responsibilities may include supply chain risk mitigation management and oversight of the execution of Strategic Supplier Agreements. The Supplier Program Specialist will handle supplier change notifications and participate in the company’s change control responsibilities. The Supplier Program Specialist will also participate in the company’s efforts to work with suppliers on Corporate Social Responsibility (CSR). In addition, this role will support the company’s efforts pertaining to Regulatory & Compliance projects that are affiliated with the company’s supplier base.
Essential Job Duties and Responsibilities
1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Perform other duties as assigned.
3. Responsible for leading program meetings for Supplier Review Board and Materials Review Board per relevant Standard Operating Procedures (SOP’s) and Work Instruction Documents (WID’s).
4. Gather, analyze, and prepare supplier documentation and performance trends per relevant SOP’s and WID’s, which includes Non-Conformances, Supplier Corrective Actions, and delivery performance data.
5. Works with Quality Assurance to manage the Approved Supplier List (ASL) to guarantee that we are working with suppliers that are compliant in doing business with the company.
6. Instrumental in all BSI, FDA, IVDR, MDSAP, and internal audits by ensuring suppliers are compliant to the rules and regulations.
7. Train as an ISO 13485 certified auditor and assist the Quality Assurance department with supplier audits as needed.
8. Coordinate with the Change Control Board by attending meetings and track completion of implementation orders.
9. Maintain and update supporting supplier documents which include Supplier Checklists, Surveys, ISO Certificates, NDAs, Contracts, and other applicable documents to align with current regulatory and compliance standards (ISO; IVDR; REACH; etc.).
10. Improve, enhance, and keep the supplier program in compliance with FDA and ISO 13485 standards as directed and aided by direct Manager.
11. Other responsibilities may include supply chain risk mitigations, corporate social responsibility, and regulatory compliance.
Information that will enhance the understanding of the nature of the job (e.g., number of people directly supervised, total staff supervised, sales volume impacted, operating budget, extent of travel required, etc.)
• The Supplier Program Specialist will work with several departments and on cross functional teams to accomplish the job directives.
• Approximately 15% domestic travel and 5% international travel may be required.
Training and Education
Minimum education and/or training requirements for this position (i.e. high school diploma, college degree, and/or certification).
• Bachelor’s Degree in Business Administration or related field.
• Relevant advanced, technical degree, or MBA is a plus; PMP Certificate is also a plus.
Minimum time and type experience required for this position.
• 2 Years of experience in a directly related field.
• Experience in supplier quality programs and ISO quality audit experience preferred.
• Experience in the medical device or biotech industry is preferred.
• Previous experience in leading teams is preferred.
Knowledge, Skills and Abilities
Knowledge, special skills and/or abilities required to perform the job functions (e.g., negotiation, technical writing; statistical evaluation).
• Excellent reading, writing, and communication skills.
• Attention to detail.
• Ability to complete objectives without high levels of supervision.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, and Visio).
• Experience with business analysis software such as Domo or Tableau.
• Self-motivated, and able to manage time effectively.
• Critical and innovative thinker.
• Desire to work hard and learn; humility; strong work ethic; coachable; team player; and strive for excellence.