- Bridgend, Wales
- Embedded Software
Our client produces Medical Devices and this Quality Engineering role will provide quality engineering cross functional support within the product development and manufacturing environments ensuring products are designed, developed and manufactured to exceptional quality standards. Improve the quality systems and quality processes within the company to enable strategic business objectives and goals to be achieved.
Roles and Responsibilities
- The Quality Engineer will support and improve the design processes in product development and manufacturing.
- Ensure that the development of products complies with FDA, ISO 13495, BS 62304 and other medical device regulations.
- Ensure that technical documentation adheres to approved processes and complies with the relevant regulations.
- The Quality Engineer will support Technical and Design Reviews from a quality engineering perspective
- Create and manage Design History Files and documentation roadmaps
- Train engineering groups in the quality processes
- Develop the CAPA and Non-conformance reporting process.
- Develop the complaints handling, issue, documentation and statistical reporting management systems.
- The Quality Engineer will develop the Internal Audit Program and support Notified Body Audit/External Audits.
- Introduce an NPI process for design and operations collaboration
- Suggest and support improvements of the QMS
- Manage and coordinate the weekly input to the KPI process, to ensure objectives are met.
- The Quality Engineer will provide ongoing support for change control activities.
- Daily support for all activities that feed into the centralised approach for the QMS
- Champion a quality and continuous improvement culture within the company.
- Education: Engineering or scientific degree with experience in quality engineering or equivalent work experience
- Work experience: Minimum 2-5 years in the medical device industry or similar regulated industries
Essential - Experience
- Experience of software design methodologies and software development lifecycles.
- Experience with quality management systems.
- Experience with quality system audits.
- Knowledge of product development lifecycles.
- Knowledge of testing strategies, verification and validation.
- Knowledge of Project Management, Lean, Six-Sigma and 5S methodologies.
- Knowledge of relevant international standards, regulations and guidelines (EU Directives, MEDDEV guidelines, FDA regulatory standards, FDA 510(k), ISO 13485, BS62304)
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