QA Engineer

3 hours ago

Sligo, Ireland Pale Blue Dot Recruitment Full time

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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