Supplier Quality Engineer

Posting Date 2 months ago(12/2/2021 3:13 PM)
Requisition ID
2021-9912
Job Location(s)
Spencer IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Capital Equipment
Category
Quality

Overview

The Supplier Quality Engineer 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.ss risks and benefits in order to provide recommendations to support production activities (ie. Change Orders, validation support, system breech, etc.).
- 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 maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Qualifications

- Bachelors degree in Engineering, Management or a related field; or experience of such kind and amount as to provide a comparable background required
- Minimum 2 years of experience working in a Medical Device or Life Sciences Quality Management System (preferred).
- Proficient in quality tools including but not limited to: Data/Statistical Analysis, Root Cause Analysis, Fault Tree Analysis (FTA), Fishbone, etc. (preferred)
- Proficient in Microsoft Office and in desktop and mobile technology.
- Auditor certification (ASQ or equivalent) is preferred.

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