Job Description

Overview

The Supplier Quality Engineer at Cook Inc. is involved in supplier qualification and monitoring of supplier quality.

Responsibilities

Responsible for quality activities related to selecting, developing and maintaining suppliers including:

- Lead supplier audits including pre-audit supplier research, planning/coordination, report writing, and audit finding follow up.- Qualify new suppliers.- Evaluate supplier change requests.- Generate Supplier Corrective Action Requests (SCARs) including issuance, evaluation, and effectiveness monitoring as required and follow up with Suppliers for completion/closure.- Monitor quality performance of suppliers .- Negotiate quality agreement terms.- Act as liaison between suppliers, engineering, and manufacturing.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.

Qualifications

• Bachelor's degree in Engineering• Knowledge of medical device regulations, pertinent standards and guidances • Knowledge of quality tools & principles (i.e. risk assessment)

• Knowledge of Cook product lines/usage preferred• Knowledge of Cook quality system and associated documentation preferred

- Knowledge of medical device regulations, pertinent standards and guidances. - 5 years of Supplier Quality experience preferred. - Auditor certification (ASQ or equivalent) is preferred.

Physical Requirements:

• Works under general office environmental conditions• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.• 20-30% travel required