Job Details
Senior Quality Engineer
- ID
- 14849
- Location
- Galway, Ireland
- Role Type
- Contract
- Contact
- Hannah Doyle
Senior Quality Engineer
Senior Quality Engineer – Post Market Design Assurance (Coronary/RDN)
Our Coronary/RDN Post Market Design Assurance team partners with internal and external stakeholders to execute post-market strategies, driving continuous improvement in products, processes, and methodologies. We foster a high-performance culture, motivating and leading teams to deliver excellence.
Key Responsibilities
- Provide Design Assurance support for sustaining engineering and product surveillance initiatives.
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR, and corporate quality and regulatory standards.
- Build and maintain strong cross-functional relationships within the organisation and with external partners.
- Support internal and external audits (MDR, MDSAP, FDA) as a key representative of the Post Market team.
- Contribute to risk management activities, providing focused technical guidance.
- Drive continuous improvement initiatives within the post-market function.
- Promote engagement and well-being initiatives for yourself and your colleagues.
Key Skills & Experience
- Bachelor’s degree (Level 8 NFQ) in Engineering, Mechatronics, Science, or a related discipline.
- Minimum of 4 years’ experience in quality, design assurance, or post-market roles.
- Strong problem-solving and critical thinking skills, with the ability to lead change and drive accountability.
- Excellent communication skills in English, both written and verbal.
- Experience in technical writing is an advantage.
- Knowledge of regulatory standards relevant to medical devices.
- Experience in Post Market Surveillance or Complaint Trending is beneficial.
This is an exciting opportunity to work in a dynamic, collaborative environment, making a real impact on patient safety and product quality.
Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.
For further information on this role please contact Hannah Doyle on 086 107 0950 or Engineering@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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