Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Responsibilities

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 non-conformances 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 to work on supply priorities and actions.Ensures Supplier Quality function tasks operates according to procedures.Collaborates with the Procurement team assigned to support supplied products and materials in a multi-functional manner.Review and approves supplier records including but not exclusive to: quality agreement, quality plans & SCARs/CAPAs.

Requirements

Degree in Engineering, Biological Sciences or equivalentMinimum 5 years of relevant experience in manufacturing industry.Supplier Quality role with medical instruments/devicesISO13485 or/and ISO 9001 internal Auditor certified is preferred..Knowledge of IS0 13485 and 21 CFR Part 820.Able to work independently and self-motivated.Excellent oral and written communication skills.