Role: Quality Systems Engineer
Industry: Medical Devices
My client, a SME medical devices company in the heart of Galway have opened up a new job opportunity on their team for an experienced Quality Systems Engineer.
This is a permanent opportunity and will give the successful candidate the following responsibilities int heir role:
- A leader and expert in the areas of quality systems, applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, & 21CFR11.
- 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. Under the direction of the Senior Quality Manager, will lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.
- Participate cross functionally and across the business to standardize and continually improve the Quality System policies and procedures.
- 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 to schedule and maintaining/supporting the supplier quality management process.
In order to qualify for this role you must be able to offer the following experience/qualifications:
- Degree/Post-Grad in Quality Management
- 5+ years' experience in a medical device manufacturing environment with direct experience in a Quality Systems role and with exposure to FDA / ISO13485 / CE Registration Process.
- Experience with involvement in design/process validations and FMEAs would be a distinct advantage.
- Lead Auditor or Internal Auditor certification an advantage.
To hear more about this opportunity, submit an up-to-date CV.
Shortlisted candidates will be contacted over the coming days.
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