My client are a start-up medical device company based in the heart of Galway. A fast-paced company with a brilliant work culture, this opportunity is not to be missed. My client are currently looking for a Quality Engineer who can come in and establish and maintain an effective quality system structures to ensure consistent implementation of quality systems.
- Good knowledge and application of quality system regulations and ISO standards.
- Constantly promotes awareness of best industry practices making appropriate decisions on a daily basis. Champions continuous improvement from a quality system perspective and educates functional areas on quality system requirements.
- Implementation of internal requirements and external laws, regulations, guidance's and standards, as applicable to the company's quality systems.
- Participate cross functionally and across the business to standardize and continually improve the Quality System policies and procedures.
- Lead and support Regulatory Inspections and Notified Body audits.
- Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.
- Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.
- Conducting internal audits and maintaining the supplier quality management process.
- Supporting and providing input into equipment/process validations and test method validations.
- Supporting operations, clinical and R&D functions from a quality perspective as required.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
Skills, Qualification & Experience:
- Degree/ Post-grad in Quality Management (ideally)
- 5+ years experience in a medical device manufacturing environment with experience in Quality Systems and ideally with exposure to ISO13485
If interested, please apply directly and I will contact you with further details.
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: Amy Simpson
Job ID: 2795273