Ref No: DT18048x
County Sligo, Republic of Ireland
Quality Engineer - Co. Sligo.
We are seeking a Quality Engineer to join our client firm on a full time, permanent basis in Co. Sligo.
Our client firm strives to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package.
The responsibilities for this position will include the following:
• 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 the maintenance, 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.
• 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.
The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.
• 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.
This is a full-time position on a Permanent contract with a view to starting as soon as possible.