Senior Quality Engineer
Senior Quality Engineer - Cork
Excellent opportunity for a Senior Quality Engineer to join a Quality team based in a medical device company in Cork. You will be joining a multinational company with an SME feel and an exceptional company culture.
About the role:
You will report to the Quality Director and you will be responsible for assisting/ leading the implementation of projects associated with process development and manufacturing transfer and validation through development life cycle phases.
You will assist in global projects in order to contribute to continuous improvement of the Quality system and facility. Proactive in identifying budget, risk assessments and resources needed to facilitate project. Track project to completion and ensure compliance in line with company regulations.
You will have the opportunity to:
- Facilitate the definition of project scope, goals, objectives and deliverables with management, supporting business strategies.
- Create documentation associated with Quality Engineering activities including quality plans, validation protocols and reports and update Quality System procedures.
- Monitor and report on progress of the project to all stakeholders, identifying risks and steps for mitigation. Eliminating issues or delays as appropriate
- Identify and implement and manage project changes to achieve project outputs within required timelines.
- Ensure adherence to regulatory requirements: RDC, ISO and FDA.
- Participate, as required, in the development, validation and improvement of the manufacturing processes for existing and new products and processes, both internally and globally in Wright.
- Interface with Suppliers for new processes, quality issues and process improvements.
- Any other duties as determined by the Quality Director.
- Degree in engineering or a technical Science degree.
- 3-5 years experience in a Quality role within medical device industry is a must.
- Excellent working knowledge in Quality Systems and ISO 13485:2016.
- Minimum 3-5 years experience in a manufacturing environment - distinct advantage.
- Project management experience.
For more information please don't hesitate to call Aoife on 086 044 3981 and I would be happy to discuss the role with you in more detail.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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