Senior Quality Engineer
A home grown Medical Device company with a focus on innovation for acute care aerosol drug delivery, they are one of the fastest growing companies in Ireland at the moment, meaning that there is plenty of room for growth and development with them.
The Senior Quality Engineer in this role will be responsible for leading and supporting projects and ensuring that all Quality related activities are approved and performed in accordance with both local procedures and the relevant statutory requirements.
Competitive salary, Pension, Healthcare, Annual Bonus
- Managing Product and Process Verification and Validation activities as related to product/ process in question.
- Leading Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer's, Cost Improvements, and New Product Introductions etc.
- Manage activities within the project teams.
- Leading investigation of quality issues should they arise during day-to-day production or within projects.
- Liaise with the Supplier Quality group to ensure Supplier Approval Requirements are met.
- Ensuring conformance with current equipment, process, and systems validation regulations.
- Determine process inputs and factors for variation where process capability is required
- Work with R&D and other cross functional teams to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
- Provide timely and accurate reporting and management of escalations on project activities.
- Establish analysis techniques and other quality control tools and utilisation of these to solve specific quality problems.
- Overall responsibility for GMP, ISO and FDA standards and compliance within Project Teams.
Using appropriate risk management to prevent unanticipated failure modes and help improves the capability of processes.
- Ensure that all health, safety, and environmental requirements are fulfilled
- Supporting external audits, internal audits and any relevant Quality/Regulatory compliance related activities.
- Minimum Level 8 qualification in Science, Engineering or a related discipline, with a relevant post graduate qualification in Quality Assurance preferred.
- 5 years' experience in Quality Assurance role in a regulated industry, with a minimum of 3 years Supervisory / Management experience in a Medical Device /Pharmaceutical regulated industry
If this role looks like something you might be interested in, please apply here and I will give you a call with some more information.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Contact Name: Tara Toomey