Quality Engineer - Sligo

Job Overview

My client, a Med Device Company, based in Sligo, are looking to hire a Quality Engineer to join their expanding team in Sligo.

You will provide technical quality support to Project Manager, Design Engineers, Production manager and clients. You will also work closely with Engineering team and the client to establish and maintain compliant product specifications.

What is my client offering you?

  • You will have an amazing opportunity to join a successful and expanding team.
  • Excellent salary and benefits package
  • Excellent opportunities for career progression and advancement.

Key Responsibilities include:

  • 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 sterilise product.

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.

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