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QA Engineer

  • On-site
    • Sligo, Connaught, Ireland
  • Quality Assurance

Job description

Our client, a medical device engineering company, in Sligo, are offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market are seeking a Quality Assurance Engineer to join their team.


Responsibilities include but are not limited to:

  • Provide technical quality support to Project Manager, Design Engineers, Production manager and clients.
  • Work closely with Engineering team and the client to establish and maintain compliant product specifications.
  • Quality review of process validation plan, protocols, and reports.
  • Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.
  • Issue, review, and release of lot records to manufacturing.
  • Co-ordinate and review of testing and release of sterilized product.
  • Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures.
  • Review and approve product change controls.
  • Liaise with suppliers and clients on quality related issues.
  • Perform an active role in further development and continuous improvement of the QMS.
  • Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.
  • Perform CAPA reports.
  • Support clients in product submission to applicable regulatory authorities.
  • Support Quality Department in implementing and maintaining QMS.
  • Conduct internal audits and compilation of associated documentation.
  • Support and assist in the preparation for customer and surveillance audits.
  • Updates job knowledge by participating in educational opportunities.
  • Other such duties as may be assigned from time to time by their manager.

Job requirements

  • Minimum Degree in a Science or Engineering discipline.
  • 3-5 Years’ experience working in a medical device environment.
  • Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
  • Strong knowledge of MDR & FDA product submission requirement.
  • Internal/external auditing experience would be an advantage.
  • Validation experience including Sterilization, process and packaging validations would be beneficial.
  • Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
  • Strong understanding of the general principles of ISO 14971.
  • Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required.
  • Demonstrate detailed working knowledge of the medical device industry.
  • Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers.
  • Self-motivated, flexible with a desire to learn new tasks.
  • Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.
  • Capacity to maintain the highest level of confidentiality internally and externally.
  • Excellent MS Office experience (Word, Excel, PowerPoint etc.).
  • High level of teamwork and engagement.


Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies

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