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Supplier Quality Engineer 9/2/2016

Medical Device Company Indianapolis, IN

Company
Medical Device Company
Job Classification
Full Time
Company Ref #
28612626
AJE Ref #
576077836
Location
Indianapolis, IN
Job Type
Regular

JOB DESCRIPTION

APPLY
Supplier Quality Engineer:

Are you interested in working for a premier Medical Device firm that is exploding with growth- Do you have a passion for quality engineering and have experience working with suppliers-

We are partnering with a Medical Device firm seeking a Supplier Quality Engineer. This individual will manage the supplier base of 400+ contract manufacturing organization (CMO) & non-CMO suppliers.

General responsibilities include:
- Supplier audit and approval
- Supplier selection and qualification
- Requesting of corrective actions
- Ensuring suppliers are responding appropriately and on-time to SCARs, etc.
- New product development activities
- Actively participate in supplier selection, audits, improvement and qualification in support of existing and new products.
- Thorough understanding of Quality Plans and Quality Agreements.
- Problem solving through classical & experimental design methods.
- of receiving inspection processes with applicable regulatory requirements.

QUALIFICATIONS
- Bachelor's degree in a technical engineering field
- Thorough understanding of 21 CFR Part 820, ISO 13485, AAMI / ISO 11135
- ASQ CQA, CQE, Lead Auditor certification to ISO 13485, Six Sigma Green Belt or Black Belt strongly preferred.