Job Description
Quality Engineer Position
We are seeking a Quality Engineer to join our team in County Sligo, Republic of Ireland.
* Provide technical quality support to project managers, design engineers, production managers, and clients.
* Work closely with the engineering team and clients to establish and maintain compliant product specifications.
* Conduct quality reviews of process validation plans, protocols, and reports.
* Coordinate and contribute to the generation and maintenance of compliant product risk management files.
* Issue, review, and release lot records to manufacturing.
* Coordinate and review testing and release of sterilized products.
* Conduct quality reviews of SOPs, work instructions, templates, material specifications, etc. to ensure compliance with 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 compile associated documentation.
* Support and assist in preparation for customer and surveillance audits.
* Update job knowledge by participating in educational opportunities.
Required Qualifications:
* Minimum degree in a science or engineering discipline.
* At least 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 requirements.
* Internal/external auditing experience would be an advantage.
* Validation experience including sterilization, process, and packaging validations would be beneficial.
* Knowledge of medical device manufacturing environments 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 prioritize.
* 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.
* Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.
* Excellent MS Office experience (Word, Excel, PowerPoint, etc.).