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Quality Engineer

  1. Cork
Sligo
  1. Contract
Competitive
  1. Compliance / Quality Assurance
31-05-2024
34291
Quality Engineer - Ireland - 12-Month Contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Quality Engineer to join their state of the art pharmaceutical facility.

Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.


Responsibilities: 
  • Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
  • Audit the quality system with other personnel where required.
  • Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
  • Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
  • Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.
  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
  • Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
  • Ensure implementation and compliance with relevant Regulator requirements.
  • Assist in the performance of validation activities at the site.

Requirements: 
  • Degree in an Engineering, Science, Quality or other discipline
  • A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
  • 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
  •  Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
  • Experience in an injection moulding or tooling environment is desirable.
  • Has a personal responsibility to commit to the Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and Ways of Work.
  • This role is accountable for supporting a positive developmental culture with the organisation while ensuring compliance with Quality policies.
  • Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organisational needs.

If this role is of interest to you, please apply now!

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