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Senior Quality Engineer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Other
  • Date posted: 26/02/2018
  • Job reference: J380350A

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Senior Quality Engineer

Senior Quality Engineer required to join a leading medical device company in the South East on a permanent basis. This role is responsible for ensuring that the Manufacturing Quality System requirements are effectively and efficiently embedded in the manufacturing processes accordance the company's Quality System and all relevant external Regulations and Standards

Responsibilities:

  • Where appropriate, to refer disposition of non-conforming materials to Manufacturing Quality Manager.
  • To provide support to the Manufacturing Quality Manager in maintenance, review and improvement of the quality management system.
  • Understand & review validation documentation, change requests, design & process FMEA's
  • To provide quality oversight for the Film process, provide input and approve validation documentation, update PFMEA and risk assessments.
  • To oversee Product Quality that meets Customer requirements.
  • To Manage Non-conforming product and ensure effective resolution of Quality problems.
  • To assess & challenge established Quality Systems and Quality methods with an objective to improve overall system effectiveness, and to reduce product and process risk.
  • To apply both a Lean and Six Sigma approach for improvements to the Manufacturing Quality Systems.
  • Drive quality improvement initiatives in combination with Process Engineering and rations.
  • Maintain/Improve good documentation practices for work instructions, SOPs & Forms.
  • Support and risk manage process change initiatives to ensure appropriate level of validation and verification.

Requirements:

  • Third level Qualification in Science or Engineering
  • Minimum 5 years' experience in a regulated pharmaceutical/medical device environment in a Quality Role essential
  • Strong analytical skills with good knowledge of process control systems.
  • Self-motivated with ability to handle multiple priorities
  • Must be familiar with the regulatory requirements of the FDA and/or ISO
  • Decisive, good communicators, self-motivated, have record of achievement and be a good team member
  • Project management experience
  • Supervisory experience desirable
  • Full understanding of the requirements of the regulatory standards
  • Experience in using Microsoft Office products
  • Kintana, Documentum, Catsweb experience is an advantage.
  • Knowledge of Six Sigma and Lean tools

For more information contact Paul on 016455257 or email

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