Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeResponsibilities and Authorities
Drive improvements and reduce risk in our Supply Chain at our Manufacturing site. Primary responsibilities of the SQE will be to qualify new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans at supplier sites to prevent repeat nonconformances using Quality Tools (FMEA,5M1E, Control Plan etc.) and perform supplier audits.Develops and ensures the execution of objectives for the control of suppliers, contract manufacturers and service providers in alignment with company goals and objectives, including assuring the acceptable product and services.Develops and/or continuously improves Supplier Quality procedures and quality assurance methodologies Collaborates with Procurement, R&D and Operations to effectively work on supply priorities and actions.Ensures Supplier Quality function tasks operate according to procedures.
Multi-functionally coordinates with the Procurement team assigned to support supplied products and materials.
Review and approves supplier records including but not exclusive to quality agreement, quality plans, change requests, SCARs/CAPAs, verification and validation protocols and reports.
Participates in the Supply Chain Risk Management teams, CAPA Review Board meetings and other critical decision-making meetings as required to define and assess supplier\xe2\x80\x99s roles, responsibilities and effectiveness.Qualification

• Degree in Engineering, Biological Sciences or equivalent

• Supplier Quality role with Medical instruments/devices.

• \xf4\x80\x80\x80 ISO13485 or/and ISO 9001 internal Auditor certified
• \xf4\x80\x80\x80 Knowledge of IS0 13485 and 21 CFR Part 820.
• \xf4\x80\x80\x80 Work independently and self-motivated.
• \xf4\x80\x80\x80 Excellent oral and written communication skills

Thermo Fisher Scientific