Quality Engineer
About the Company:
{company} is one of Ireland's leading companies in Medical Device Engineering.
About the Position
The focus of this role will be to provide Quality Engineering support to the R&D, Manufacturing teams, Design Engineers and clients.
Key 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 SOPs, Work instructions, templates, Material specifications etc. to ensure compliance to applicable regulatory standards and c GMP 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.
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 21 CFR 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 c GMP 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, Power Point etc.).
* High level of teamwork and engagement.
Remuneration Package
A competitive package is available including generous salary and benefits.