Senior Quality Engineer
Question for you – Would you like to be a key part of shaping the future of Operations Quality in a large multinational?
This position offers valuable experience in problem solving, people management and stakeholder management. You will also be involved in strategy setting for the Quality Operations organisation.
Why Join Us?
Merit Medical Galway produces 9 million life saving devices per year. Globally, we impact the lives of an estimated 15000 people per day across 120 countries. Merit Galway has enjoyed a 20% year on year revenue growth and now has 2 facilities with a workforce of 1,000. Merit Medical employs 6000 people worldwide maintaining a diverse, global manufacturing footprint in Europe, North America, South America, Asia and Australia.
At the Galway facilities almost 60% of all roles are filled by internal employees! Nurturing talent from within is a key focus for us as we continue to grow. We are focused on encouraging, believing in and providing a platform for you to progress your career!
A supportive and collaborative environment makes Merit Medical an enjoyable place to work. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.
Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry. We hold a National Irish Safety Organisation Award and the ISO:140001 Environmental Management System Award
Employees at the Galway facilities have raised significant funds for local charities including Pieta House, Breast Cancer Ireland and many more.
- 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.
A competitive salary package, Healthcare Cover, Pension, long term disability/income protection, life assurance. Employee Assistance Programme. Relocation Expenses where applicable
Onsite Wellness Programme, Active Sports and Social Club, Excellent career progression opportunities, Educational assistance programme, Internal training courses, Recognition scheme, Quality Subsidised Canteens & Barista Service and Free Parking.
Merit Medical is an Equal Opportunities Employer
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Tel: +353 1 5311 280
Fax: +353 1 5311 285