Supplier Quality Engineer

Laborie Medical Technologies Corp•Portsmouth, NH

11d

About The Position

The primary emphasis of the Supplier Quality Engineer is to assist with managing product quality through the implementation of supplier/contract manufacturer evaluation procedures, use of risk management tools, and auditing of current and prospective vendors. Identify and manage the risks associated with supplied materials and maintain and implementing quality system procedures for supplier evaluation. Use risk management tools to identify and mitigate supplier risks and participate in the supplier selection and monitoring process. Audit current or future suppliers to ensure their compliance to quality system requirements & material specifications and assist with the evaluation and disposition of nonconforming materials. Issue and provide technical direction to supplier corrective action requests and monitor and compile reports for Supplier KPI’s, Scorecards. Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment. Participate in product design and development projects as needed and provide engineering support to products including risk management activities.

Requirements

Bachelors' degree in an engineering or related scientific field
A minimum of 5 years of experience in quality assurance.
Knowledge of ISO 13485 and 21CFR compliant quality systems.
Experience with internal and external auditing.
Experience applying statistical methods to quality assurance.
Required to read and understand the following documents: Refer to the current version of the Training Matrix Q620-FRM-03 or equivalent

Responsibilities

Assist with managing product quality through the implementation of supplier/contract manufacturer evaluation procedures, use of risk management tools, and auditing of current and prospective vendors.
Identify and manage the risks associated with supplied materials and maintain and implementing quality system procedures for supplier evaluation.
Use risk management tools to identify and mitigate supplier risks and participate in the supplier selection and monitoring process.
Audit current or future suppliers to ensure their compliance to quality system requirements & material specifications.
Assist with the evaluation and disposition of nonconforming materials.
Issue and provide technical direction to supplier corrective action requests.
Monitor and compile reports for Supplier KPI’s, Scorecards.
Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment.
Participate in product design and development projects as needed.
Provide engineering support to products including risk management activities.