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Quality Engineer

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Mark Wilson
+353 86 0449473
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Recruitment Consultant

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Quality Engineer

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Quality Engineer

We have an exciting opportunity available for an experienced Quality Engineer with a medical device company in Roscommon. Our Client specialises in single use medical devices and is multi-national company with a leading name in the medical device industry. This is a permanent position, commutable from Roscommon, Westmeath, Longford, East Galway & Leitrim and will report to the Quality Engineering Manager.

Key Responsibilities:

  • Conform to the requirements of the Quality and Environmental Management System.
  • Review, update and maintain existing quality management processes and procedures.
  • Maintain detailed and accurate quality records, data analysis and documentation.
  • Raise Quality profile and operating standards within the business.
  • Deliver on all KPIs that help the business achieve its goal.
  • Support projects and initiatives across the plant where required, ensuring key deliverables are achieved in a timely manner and liaising effectively with internal and external customers.
  • Initiate and drive continuous improvement opportunities / programs.
  • Lead and drive QA initiatives within area of functional responsibility.
  • Represent quality interests and concerns on project teams.
  • Quality support within the assigned Customer and/or project teams to ensure Customer and QMS requirements are implemented and fulfilled to required GMP standards.
  • Lead Quality Engineering activities for the introduction of new product lines through development of product inspection plans, production documentation, process FMEAs and risk management plans. Ensure change requests are effectively managed.
  • Lead Quality Engineering activities for existing product lines through maintenance and continuous improvement of product inspection plans, production documentation, process FMEAs and risk management plans. Ensure change requests are effectively managed.
  • Ensure that products meet Harmac's and customers’ quality and product integrity requirements and continually seek to identify and drive improvements in product and process quality.
  • Lead and coordinate/execute process and product validations.
  • Provide quality input to cross functional team to support existing product lines with an ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance..
  • Investigate root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
  • Oversee non-conforming material, customer complaints, CAPA investigations, analysis,and improvement.
  • Utilize data analysis and trending, statistical process control, root cause analysis and implement corrective actions.
  • Utilize DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation.
  • Ensure quality inspection instruments are accurate and regularly calibrated, tested and audited.
  • Assist with ensuring that the Company retains ISO accreditation.
  • Conduct internal audits and external audits as required.
  • Host audits of the Company’s operations by external bodies (e.g., audits from customers, FDA, audits relating to certification to official standard e.g., ISO 13458)
  • Train Graduate and Junior Quality Engineers on policies and procedures and perform an active role in their development and growth.
  • Familiarize yourself with a variety of processes to allow you to work across a number of product lines

Key Requirements

  • Level 8 or equivalent Degree in Quality Assurance or similar discipline.
  • Minimum of 3 years’ experience in a Quality Engineering role with active involvement within a manufacturing floor, preferable in the medical device sector, is desirable.
  • Effective communicator and influencer across multi-functional teams, with the ability to manage internal and external customers’ requirements.
  • Knowledge of ISO 13485, ISO 14971 and QSR 21 CFR Part 820 standards.
  • Strong proficiency in statistical analysis techniques to investigate and solve problems and improve quality.
  • Project Management training is advantageous

For further information on this role in please contact Mark Wilson on 0860449473 or email

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Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.



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