Inginaire - Engineering Staffing

Supplier Quality Engineer

Location
Chaska, MN
Salary
Contact For Rate
Posted
May 13, 2017
Closes
May 24, 2017
Ref
814525-03
Category
Engineering
Job Type
Employee
Employment Status
Full Time
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Duties:
  • Improve supplier quality performance for assigned suppliers.
  • Manage supplier audit program and overall supplier approval/rating program through robust qualification processes.
  • Assure supplier compliance to Lake Region Medical QMS and regulatory requirements through supplier monitoring process.
  • Manage the supplier process change process.
  • Develop positive relationships and work closely with Engineering and Supply Chain to manage and implement supplier/engineering changes, New Product Introductions, and transfers.
  • Interface with Suppliers, Engineering, Operations and Supply Chain to drive Quality improvements that minimize the Costs of Quality, specifically Incoming Rejects, Failures, and operational defects.
  • Work with product support teams on component quality issues and supplier initiatives.
  • Work directly with vendors under the control of the Lake Region Medical QMS. This involves travel to supplier sites so this person must be available to travel at short notice.
  • Support implementation of initiatives such as Supplied Data and Dock to Stock.
  • Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
  • Develop and support Supplier Quality Engineering program.
  • Review document and procedure changes for quality requirements and compliance with the quality system.
  • Provide quality support for the disposition of material.
  • Support the implementation of continuous improvement initiatives for productive processes.
  • Comply with all work rules including those pertaining to safety, health, and quality.
  • Provide leadership and guidance to QC Technicians who perform receiving inspection activities.

Requirements:
  • BS degree in engineering or related discipline.
  • Minimum 5 years’ experience in medical device manufacturing, 3 years in quality assurance
  • Strong experience with ISO 13485,QSR, and/or ISO9001 systems
  • ASQ certified quality engineer/manager desired
  • ASQ or equivalent auditor certification desired
  • Must have the ability to interact professionally, with associates at all levels of the organization.
  • Keyboarding required for inputting and analyzing data, memorandums and reports.
  • Self-started with the ability to facilitate activities with little direction
  • Deadline sensitive with a high degree of concentration.
  • Attention to details.
  • Must be able to work with diverse groups within the company.
  • Must be able to think critically about technical matters that may impact upon the fit, form or function of Lake Region’s product.
  • High visual and tactile demand.
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