On offer is an opportunity for a Quality Engineer with electrical medical device knowledge to fast track there career with a growing organisation that really cares about its employers.
My client is an established international consumer health and medical technological business that is growing globally at an extensive rate. With the Global HQ based in the UK and manufacturing across the Far East they are continuing to grow through design and developing market innovative consumer health products.
This is a great opportunity for a Quality Engineer who is looking fast track their career joining an established consumer health and medical technological business that will encompass a number of different responsibilities. You will play a pivotal role in Design Control and Change Control projects, assuring that products are designed and maintained in a manner compliant with all applicable global Quality System Regulations. This includes the creation and maintenance of design history files and risk management files for electrical medical devices throughout the product lifecycle. Other responsibilities include;
- Ensure that products are designed, delivered and maintained with the correct focus on quality and risk, and in compliance with Quality Systems Regulations.
- Provide quality leadership to project teams to ensure that appropriate quality controls and procedures are in place.
- Actively participate in and/or facilitate the development, review and approval of product requirements and specifications
- Own Risk Management activities; ensure Risk Management Plans are in place and activities are delivered accordingly - i.e. manage the creation of risk assessments; including the definition of suitable mitigation actions and demonstration of appropriate validation.
- Qualify, monitor and audit suppliers; review and / or develop work instructions and quality plans, ensuring correct quality control checks and measures are in place.
- Identify quality issues and appropriately manage resolution - e.g. assess product failures and implement appropriate non-conformance reports and corrective and preventative actions. Support continuous improvement activities including CAPA investigation, processing and disposition.
- Manage contract manufacture design control to ensure all changes are considered for impact and appropriately validated prior to implementation.
- Create, maintain and update product documentation throughout the product lifecycle (Technical File, Design History File and Risk Management Report).
- Perform all activities in compliance with relevant GMP, internal Quality Systems and safety standards and with FDA Quality System Regulation and ISO 13485.
To be successful in this role you will need to be ambitious and passionate for the brand. It is essential in having working knowledge of ISO13485 & an electrical engineering with knowledge of IEC 60601.
- 3 to 5 years previous experience of working within Medical Device development and working knowledge of relevant requirements of Medical Devices Directive (93/42/EEC, MDR 2017/745), FDA Code of Federal Regulations (21 CFR Part 820) and Canadian Medical Device Regulations (SOR/98-282).
- Experience of Electrical Engineering a must with working knowledge of IEC 60601 and the ability to undertake electrical testing and fault finding.
- Experience of undertaking and managing risk assessments in line with ISO 14971:2012.
- Excellent communication skills
- Ability to work in a team environment and fast track your career
- The successful candidate will have full breadth of the organisation globally (rather than a large organisation with a role that will inherently be narrow focused).
- They will have exposure to the CEO and Group Finance Director as well as country General Managers.
On offer is an opportunity for a Quality Engineer with electrical medical device knowledge to fast track there career with a growing organisation that really cares about its employers. The base is salary is dependent on experience between £30,000 - £45,000 + package.
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job