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QA Specialist

Company:
Spectraforce technologies Inc.
Location:
Illinois, United States
Posted:
December 06, 2018

Description:

QA Specialist III

Duration: 12 months, Contract

Location- Buffalo Grove, IL 60089

Description

This Senior Quality Professional position is focused on supporting a new manufacturing line in the Chicago area for our Freestyle Libre product (recently PMA approved). The ideal candidate has experience in one or more of the following areas; injection molding, components, process engineering, process validation, automation and supplier quality engineering within the medical device industry, in a high volume environment.

Main Responsibilities:

Supports in the selection, approval and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. Ensures manufacturing processes are validated as applicable and products meet quality requirements.

Communicates division’s approval requirements to supplier and monitors feedback per project timelines.

Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate. • Leads in the evaluation and approval of supplier requested changes or improvements. This activity may also include the identification and/or approval of a new supplier to provide an alternate material, or changes in parts or processes used at the supplier/TPM.

Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.

Monitors supplier performance and reports supplier quality trend data. Drives improvement projects, as required, to improve supplier performance.

Performs on-site quality assessments of new suppliers, as required

Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits).

Ensures appropriate corrective action response to findings.

Notifies suppliers of customer complaints related to the Agile Manufacture's Tab

Requirements

Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).

BS degree and/or 5+ year’s equivalent experience