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Supplier Quality Engineering

Req #: 1600048W_de
Location: Hechingen, BW DE
Job Category: Quality
Date Posted: 8/11/2017 10:42:27 AM
Baxter International

Description

Support supplier quality management assurance for Dialyzers, including the performance of materials, components, devices and services provided to Dialyzers plants, (i.e., raw material, components, subassemblies), to ensure the highest quality for those products as defined by Gambro specifications and requirements. Responsibilities will include, but are not limited to:
  • Support/execution of suppliers auditing in accordance to the pertinent Gambro procedures, guidelines and requirement specific to the supplier classification
  • Implementation of key quality indicators to monitor and keep suppliers in control in accordance to predefined targets
  • Support all quality supplier activities for Dialyzers areas, including supplier quality assessments, corrective actions, root cause analysis, and risk assessment. 
  • improvement through effective partnership is one of the primary objectives of this position. 

 

PRINCIPAL RESPONSIBILITIES: 

  • Support strategies implementation for supplier quality initiatives for Dialyzers business.
  • Overview technical and quality documentation provided to the supplier and guarantee suitability of processes at supplier facility a product quality as per specifications.
  • Overview pertinent process qualification plans and reports to assure components and materials meet specified requirements for performance, reliability and safety.
  • Work as team member with key persons responsible for other areas as the Global Supplier management organization, Global QARA organization and QA Operations to proactively affect the product/process quality.
  • Monitor, analyze and identify trends from quality and performance data, developing proactive measures to continually improve performance to achieve preferred supplier status.
  • Work as part of cross functional/cross organizational teams, developing strong relationships with the supply chain, design, manufacturing and quality groups. 
  • Support Identification and implementation total cost of ownership reduction opportunities including Cost of Poor Quality and value engineering improvements
  • Perform regular supplier quality monitoring by measuring key indicators in close collaboration with the Quality organization
 
MOST RELEVANT AUTHORITIES
  • Authority to support/execute suppliers auditing for the Dialyzers area in accordance to the pertinent Gambro procedures, guidelines and requirement specific to supplier class.
  • Authority to define, propose and follow-up at supplier level key actions and improvements to contribute achieving the highest levels of efficiency, quality and cost savings.
  • Authority to implement and monitor key quality indicators to keep suppliers in control in accordance to predefined targets on the quality of the provided products
  • Authority to guarantee effectiveness verification of the corrective actions taken at supplier facility

Qualifications

  • Minimum 5 years in Quality Assurance and Quality Control with 2 years of experience in supplier quality.
  • University degree in engineering or related field
  • Experience in product defects identification in field and in production, root cause investigation (design and production) 
  • Certified internal auditor (in accordance with ISO 19011) preferred
  • Sound knowledge of FDA, ISO, and CE Marking and industrial standards associated with product development and manufacturing.
  • Knowledge of the standards applicable to the relevant medical devices, including Risk Management
  • Knowledge of the components/formulas and of the validation process
  • Knowledge of the microbiological characteristics related to production of  terminally sterilized   fluids   in controlled areas and the process of sterilization
  • Knowledge of dialysis treatments, dialysis systems and associated defects
  • Knowledge of health, environment, and safety and of the impact of establishment processes and environmental emergencies
  • Knowledge of dialysis treatments, dialysis systems and associated defects is preferred
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