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Senior Quality Engineer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 15/10/2018
  • Job reference: BBBH90492

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Senior Quality Engineer

A Senior Quality Engineer is required to join a leading Medical Technology company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for supporting the Research Centre Ireland (RCI) site, RCI Project teams and/or other projects intended to enhance RCI's operational effectiveness including the initial creation of a Quality Management System for the RCI site. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the industry in Ireland.


Key Responsibilities

  • Creation of quality processes and procedures at the RCI site which support design control, process control & validation, supplier management and technology transfer based on industry and best practices.
  • Accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams.
  • Assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.
  • Initiate quality initiative projects, become thoroughly knowledgeable with all aspects of quality engineering and new product development and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities.



Quality Systems development

  • Begin to develop Quality system to support design activities
  • Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards
  • Support new product development activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development.
  • Guides the successful completion of major programs and may function in a project leadership role.



Qualifications

  • A minimum of 5 years of experience working within a quality function.
  • A minimum of 5 years of experience working in an FDA or ISO regulated environment.
  • A minimum of a bachelor's degree is required.


Education/Experience

  • BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science
  • Certified Quality Engineering (CQE) preferred.
  • Robust understanding of QSR, Design Control, ISO, Product Risk Management (ISO 14971) and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
  • Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.



Interested?
Please call Jack on 01-6455250, or email jack.conway-kenny AT experis.ie for more information