Senior Quality Engineer

This job has now expired please search on the home page to find live IT Jobs.

Title: Senior Quality Engineer

Location: Ballybrit, Galway

Benefits: Excellent salary, pension, healthcare and yearly bonus. Positions is with a view to move to Management level in coming years.Company:

My client are a Medical Device company, Endovascular Specialists who developed a site in Galway over 8 years ago. Started in Germany and now a worldwide company they are going from strength to strength steadily growing in Ireland.This role provides key support to the Quality function and includes:

* Managing key Quality personnel and providing technical support for the manufacture of existing products and support of design and development of new products

* Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.

* Understanding quality, business, health & safety systems and market/legal regulations and associated Regulatory Standards

* Mitigating against risks associated with the design, use and manufacture of devices.

* Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work

* Establish, implement and maintain effective quality management system requirements.

* Reporting to top management on the performance of the quality management system, and ensuring the promotion of awareness of regulatory requirements throughout the organization.

* Ensuring compliance to regulatory requirements appropriate to the quality management system; medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, TGMDR & RDC 16/2013.Skills, Qualifications & Experience

* A graduate of Engineering/Sciences with Minimum 6 years' experience in a pharmaceutical/Medical Device environment

* Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.

* Design for Manufacturing and lean manufacturing experience is a plus.

* Excellent interpersonal and communication skills with good leadership abilities; high level of self-motivation

* Demonstrable ability to work in a multi-disciplinary, regulated environmentIf you are interested in applying forward an up to date CV and we can organise a time to discuss further. To find out more about Real please visit www.realstaffing.comReal 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