Quality Engineering Manager
My client, an established Manufacturing and Production business are recruiting for a Quality Engineering Manager to join their business. The role is based at their well-established and modern facility based in Caernarfon.
A globally established business, specialising in a number of different industries.
Core responsibilities for the Quality Engineering Manager are as follows:
- Ensure effective operation of control of non-conforming product system to ensure compliance and continuous improvement of the business.
- In conjunction with site Procurement, ensure effective delivery and operation of the site supplier quality assurance management process to ensure compliance and business needs are met in conjunction with procurement. Where appropriate, this will involve leading or participation in supplier audits.
- Ensure effective delivery and operation of the site risk management process to ensure compliance and business needs are met.
- Involvement in and, where appropriate, leadership in various improvement projects in relation to control of non-conforming product, CAPA, calibration, risk management and supplier quality assurance to support continuous improvement of business systems.
- Responsible for protocol review and approval in relation to design change and process validations. Communicate effectively, providing relevant information in a timely manner, both verbal and written, with direct reports, peers, line management and your customer base to build trust and co-operation across the business.
- Ensure that staff responsible to you comply, at all times, with the relevant Quality and Environmental Standards, e.g. ISO 13485, ISO 14001, OHSAS 18001, US FDA Quality System Regulations (QSR 21 CFR Part 820), and relevant European Directives as documented within our company Quality Management Systems.
To qualify for the Quality Engineering Manager role the successful candidate will have to:
- Demonstrate experience in Quality Systems and GMP environment preferably with Immunoassay/IVD.
- Proven delivery in a manufacturing environment and demonstrated understanding of GMP/regulated environment is essential.
- Proven leadership ability (with an emphasis on coaching, mentoring, and training) with excellent communication skills at all levels.
- Expected to be able to effectively communicate and work with a variety of personnel at various levels.
- Educated to Degree or Higher National standard in a scientific / engineering discipline. Previous experience within a Regulated Industry would be advantageous.
Competitive salary with additional benefits