Senior Design Assurance Engineer – Cardiology
Work within one of Ireland’s biggest employers and one of the world’s largest medical device companies who have massively invested in their Galway site with the aim of developing their product lines and growing the site for the future with NPI and NPD projects.
Job Purpose and Responsibilities:
- Show a commitment to patient safety and product quality by collaborating with R&D, RA, Quality and Process development teams to ensure compliance to internal protocols and procedures and external regulatory requirements
- Develop quality systems in line with updates to quality policies and global regulatory requirements
- Provide regulatory and product design expertise to lead risk management and design control activities
- Utilise your expertise in validation techniques to assist in product testing and compliance coming from product complaints, updates or developments
- Be a leader within quality engineering for formulating strategy and product development
- Co-ordinate various members of other teams and supervise and support them through product development and change projects, ensuring compliance to internal and external standards
- Coach and mentor other staff to ensure full commitment to product excellence
Qualifications and Experience Requirements:
- Must have a level 8 or higher degree within STEM with 5 years or more experience and prior leadership or people development skills
- Knowledge & understanding of EN ISO 5840-3 is essential
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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