Quality Engineering Manager (Medical & Pharmaceutical)

Quality Engineering ManagerManufacturing: Medical Devices & PharmaceuticalExcellent Salary + Bonus + Relocation Assistance + Package + Genuine Opportunities for Career Progression-An excellent opportunity for a Quality Manager or Senior Manufacturing or Production Engineer with a background in quality management to join a global market leading manufacturer of sophisticated medical devices-Based in North WalesThe Company - Quality Engineering Manager, Medical Devices & Pharmaceutical My client is a global leader in healthcare. This organisations impressive portfolio of products and fully integrated medical systems incorporates all aspects of the healthcare equipment sector, and includes healthcare IT systems, medical imaging diagnostics, respiratory systems, medical laboratory diagnostics solutions, critical care and anaesthesia delivery, healthcare informatics, molecular imaging and patient monitoring systems. Offering 'best in class' solutions across a wide range of equipment modalities, their success is based upon a commitment to world leading manufacturing facilities, outstanding product innovation, excellent customer care and the recruitment and development of good people. They employ over 35,000 people globally and are an integral part of an instantly recognisable technology group.The Role - Quality Engineering Manager, Medical Devices & Pharmaceutical The Quality Engineering Manager will ensure compliance with ISO13485, FDA 21 CFR Part 820 and other International Regulatory requirements and business needs are met through the delivery and operation of effective control of non-conforming product (Quality Notifications), Design Change/Validation protocol approval, calibration, risk management and supplier quality assurance systems.This is accomplished through effective implementation of policies, procedures and practices that are aligned with the LD objectives and imperatives; and effective interactions with the leaders and key stakeholders in other functions of the LD organisation.This role will have several direct reports and will primarily encompass manufacturing support activities. This role reports directly to the site Head of Quality. Responsibilities include: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.Your Background - Quality Engineering Manager, Medical Devices & Pharmaceutical Applicants of interest should have the following background:Demonstrated experience in Quality Systems and GMP environment. 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 levelsExpected 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.The Benefits - Quality Engineering Manager, Medical Devices & Pharmaceutical In return, my client is offering a fantastic remuneration and benefits package, including competitive basic salary, bonus scheme, excellent benefits, and the opportunity to progress within a truly global market-leading organisation.For instant consideration, please forward your CV to the contact below.North Wales, Powys, Conwy, Flintshire, Gwynedd, Denbighshire, Bangor, Caernarfon, Isle Of Anglesey, Llandudno, Caernarfonshire, Wrexham, Rhyl, Colwyn Bay, ChesterThis vacancy is being advertised by TRS Consulting (UK) Limited. The services advertised by TRS Consulting (UK) Limited are those of an employment agency and / or an employment business