Senior Quality Engineer
My client are a multinational Medical Device organisation and are seeking to take on a Senior Quality Engineer on a permanent basis. They're located in the heart of Galway, where their centre of excellence is. They have a reputation for introducing and marketing innovative, high-quality products designed to enhance the practice of interventional medicine. Their Galway site has been growing 20% year on year and has over 1000 members of staff.
Do you have what it takes to be their new Senior Quality Engineer?
- Provide quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMPs of all medical device regulatory agencies (e.g. FDA, ISO and MDD/MDR).
- Ensure utilisation of appropriate problem-solving tools and methodologies and implementation of effective corrective actions.
- Supporting Quality Management in the development and implementation of quality systems, strategies and objectives.
- Deputise for Quality Manager as required.
- Ability for succession and progression planning for self, and for Quality team.
- Development objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
- Supporting and representing the site during external regulatory audits
- Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective / preventive actions to improve product quality and output.
- Mentor and coach Quality Technicians & Quality Engineers as well as staff from other functional areas on all quality related matters.
- Provide Quality performance information to members of Senior Management.
- Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
- Completion of retrospective validation, prospective validation or revalidation of products / processes / tooling or methods as necessary.
- Completion of internal and supplier audits and assessments.
- Demonstrates ownership for the integrity of work
- Able to work independently or as part of a team and consider options for completing work
- Strong written and verbal communication skills
- Bachelor's Degree in Quality or Engineering field, or an equivalent combination of education and experience.
- Must be familiar with Microsoft Office Suite
- Must have minimum of 6 years of experience in Quality Engineering field
- Experience of working in a regulated industry, preferably medical devices.
If this sounds like the role for you, please apply directly and I will contact you with further details!
To find out more about Real please visit www.realstaffing.com
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