Design Assurance Engineer with excellent understanding of ISO 13485 and FDA QS regulations required by growing medical devices client in Sligo.
Requirements:
- Minimum Degree in a Science or Engineering discipline
- 3-5 years’ experience working in a medical device environment in a Design Assurance Engineering role (preferably with involvement in Product Design and R&D)
- 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
- Desire to learn new tasks and flexibility
- 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
Desirable:
- Internal/external auditing experience
- Validation experience including Sterilization, process and packaging validations
- Knowledge of Medical Device manufacturing environment including cGMP
Responsibilities:
- Provide technical quality support for Design Assurance guidance & direction to Project Manager, Design Engineer & clients for the duration of a project development
- Work closely with Product Development Engineering team and the client to establish compliant design and product specification
- Quality review of design verification protocols & reports
- Quality review of process validation plan, protocols, and reports
- Generate & maintain compliant design history files
- Co-ordinate and contribute to the generation and maintenance of compliant product risk management files
- Co-ordinate product design reviews and compilation of associated documentation
- Issue, review, and release of lot records to manufacturing
- Co-ordinate and review of testing and release on 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
emer@emtechrecruitment.ie
