The Supplier Quality Engineer drives supply chain improvements, qualifies new suppliers, analyzes performance, implements corrective actions, and collaborates across departments.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 equivalent
- Minimum 5 years of relevant experience in manufacturing industry.
- Supplier Quality role with medical instruments/devices
- ISO13485 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.
Top Skills
Control Plan
Fmea
Iso 13485
Iso 9001
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