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Senior Quality Engineer (Design Assurance)

Ref: 76041

  • 65,000-70,000
  • 09 Nov 2021
  • Dublin (Central)
  • Permanent

Senior Quality Engineer (Design Assurance)

About the Company

A leading global manufacturer of high value packaging systems is seeking a Senior Quality Engineer with Design Assurance experience.

About the Position

Key Responsibilities

  • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; international standards; and enterprise and local procedures.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Manager, as required.
  • Review and approve relevant design history file documents; device drawings; device specifications; procedures.
  • Responsible for generating the Risk Management Plan and Risk Management Summary Report on proprietary design & development projects.
  • Facilitate risk assessment meetings with proprietary design & development teams.
  • Facilitate project risk register meetings and ensure these risk registers are maintained and updated by the relevant program manager or designee.
  • Drive the closure of change controls and protocol deviations.
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Perform first article component and products inspections

Experience/Requirements

  • Degree in a relevant Science, Engineering or Quality discipline
  • 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.
  • Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
  • Working knowledge of EU MDR 2017/745, ISO 13485, ISO 14971 and 21 CFR Part 820 is essential.
  • Working knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
  • Risk Management experience within design and development with a good working knowledge of ISO 14971.
  • An excellent understanding of plastic process manufacturing, computer systems validation, analytical methods and testing and documentation systems.
  • Knowledge of analytical tools and methods, including statistics (Minitab preferred).
  • Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
  • Must have excellent written and verbal communication skills.

Remuneration Package

A strong salary and package is on offer including healthcare, dental care and pension.
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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