Quality Engineer

Quality Engineer

• Leading Medical Device Company in the Sligo
• Excellent career progression opportunities along with a generous package.

Oradeo Recruitment is presently seeking interest for a Quality Engineer in our clients Division located in Sligo.  This position comes with an excellent remuneration package and a clear path for career growth.

Duties and Responsibilities:

• 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 sterilise 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.

Minimum requirements related to the position:

• 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.

For more information about this position or other opportunities, contact Tracey Hayden  at Oradeo Recruitment confidentially on +353 087 1005229 or apply in confidence.

About Oradeo – Oradeo Recruitment are specialists in the life sciences, pharmaceutical, construction & engineering sector. We are a leading service provider in Ireland, UK and Europe for professional recruitment services and the provision of managed labour in Construction & Civil Engineering, Data centres, Mechanical & Electrical, Life Sciences and Renewable Energies sectors