Supplier Quality Engineer

Indianapolis  ‐ Onsite
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Keywords

Description

GENERAL SUMMARY:

Provide support for Supplier Quality related activities, including managing the supplier base of 400+ contract manufacturing organization (CMO) & non-CMO suppliers, supplier audit and approval, supplier selection, qualification, corrective actions, new product development activities, and assist in Receiving Inspection operations.

KEY RESPONSIBILITIES:
  • Actively participate in supplier selection, audits, improvement and qualification in support of existing and new products.
  • Participate on New Product Introductions teams to ensure suppliers meet quality, cost and delivery requirements.
  • Monitor, analyze, and drive improvement in supplier performance, including audit findings and SCARs.
  • Assist suppliers in developing and executing process validations, statistical sampling plans, inspection methodology, and process control plans.
  • Problem solving through classical & experimental design methods.
  • Provide hands-on technical support for Receiving Inspection personnel as required.
  • Support external supplier audits, ensure compliance to department procedures and policies and drive process improvements and efficiencies in the supplier quality department.


QUALITY SYSTEMS REQUIREMENTS
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.


REQUIRED QUALIFICATIONS:
  • Bachelor's degree in a technical engineering field plus a minimum of 3 years experience auditing in the quality or medical device field
  • ASQ CQA, CQE, Lead Auditor certification to ISO 13485, Six Sigma Green Belt or Black Belt strongly preferred.
  • Excellent written and verbal communication skills are essential.
  • Requires up to 25% travel (domestic and international)


To find out more about Real please visit www.realstaffing.com
Start date
04/2013
From
Real
Published at
12.03.2013
Project ID:
502792
Contract type
Permanent
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