Our client, a medical device engineering company in Sligo, is offering a range of development and manufacturing services from initial design assessment to the provision of sterile finished products for the European and US medical device market. They are seeking a Quality Assurance Engineer to join their team.
Responsibilities include but are not limited to:
* Provide technical quality support to Project Manager, Design Engineers, Production Manager, and clients.
* Work closely with the Engineering team and the client to establish and maintain compliant product specifications.
* Quality review of process validation plans, protocols, and reports.
* Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.
* Issue, review, and release lot records to manufacturing.
* Co-ordinate and review testing and release of sterilized products.
* Quality review 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 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 the Quality Department in implementing and maintaining QMS.
* Conduct internal audits and compile associated documentation.
* Support and assist in the preparation for customer and surveillance audits.
* Update job knowledge by participating in educational opportunities.
* Other duties as assigned by the manager.
Job 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 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 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 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.
* 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.
* High level of teamwork and engagement.
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