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Job Description
Quality Engineer sought to support project management, engineering, and clients in ensuring compliance with regulatory standards and cGMP procedures.
Our client, a Sligo-based company, is expanding its operations and requires a Quality Engineer to provide technical quality support to project managers, design engineers, production managers, and clients. The successful candidate will work closely with the engineering team and clients to establish and maintain compliant product specifications.
Key Responsibilities:
- 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.
- Quality review 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 of lot records to manufacturing.
- Coordinate and review of testing and release of sterilized products.
- Quality review of SOPs, work instructions, templates, material specifications, etc.
- 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 and 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.
- Update job knowledge by participating in educational opportunities.
Requirements:
- Minimum degree in a science or engineering discipline.
- 3-5 years of experience working in a medical device environment.
- Strong knowledge of ISO 13485, FDA regulations 21 CFR 820.
- Strong knowledge of MDR and 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.
- Self-motivated, flexible, with a desire to learn new tasks.