Quality Engineer with medical devices experience required by growing medical devices company in Sligo
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 requirement
- 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, PowerPoint etc.) - High level of teamwork and engagement
- 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
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 SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to 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 Quality Department in implementing and maintaining QMS
- 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
Please send cv in confidence to emer@emtechrecruitment.ie
