Telephone: 086 8395533
Quality Systems Engineer
Our client, a medical device company in Galway are currently looking to recruit a Quality Systems Engineer for their site.
- You will contribute to identifying and supporting key areas for Quality System Improvements.
- You will be responsible for developing the system for facilitating the initiation of DOP training plans for all employees and preparing and presenting key elements of DOP training.
- You will provide the Quarterly business unit management review and quality systems and compliance induction training.
- You will support the development of the quality system to ensure applicable standards and regulations are incorporated and the development and maintenance of the system for the archive retention of quality records.
- You will ensure incorporation of corporate policies/procedures and updates to Regulations into the company Vascular Quality System.
- You will develop and implement training programmes on current and updated standards/regulations, and maintenance and review of the Quality Manual and Site Quality Plan.
- You will generate regular reviews of Departmental Operating Procedures to ensure they are maintained and updated regularly and to ensure that they appropriately reflect the applicable requirements.
- You will input into Regulatory submissions relating to Quality Systems sections.
- During external audits you will present on Quality System topics in the audit front room and also support the audit back room team.
- You will provide guidance on systems and processes relating to the Quality Systems area.
- You will also participate in CVG Council meetings.
- We are looking for a qualified person to a minimum of level 8 BSc / BEng Degree in Science or Engineering or related discipline and desirably with 2 years relevant experience.
- You are a dynamic team player and can work effectively and proactively on cross-functional teams.
- You have experience of working in a changing environment within the medical devices sector and have a strong working knowledge of the regulations and how they apply to the Medical Device and Combination Product Industry.
- You can demonstrate the leadership expectations: Sets High Standards, Drives Accountability, Initiates & Leads Change, Thinks Critically and Makes Sound Decisions.
- You can work effectively and proactively on cross- functional teams.
- You will have excellent verbal communication, presentation and technical writing skills, plus advanced computer literacy and fluent in English, both in writing and speaking.
For further information on this Quality Systems Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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