In House Engineering Quality & Continuous Improvement Lead & Service Engineer
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Job Description Summary Resonant Clinical Solutions offer a full range of clinical trial services that cover every step, from discovery to delivery. Our portfolio of custom kitting, equipment & ancillary solutions, plus biorepository & archiving services stands at the ready - to serve any trial, of any size, anywhere in the world. In this equipment & ancillaries role by MESM, you will report to our GSM (Global Service Manager) and will work closely with fellow associates to support our valued customers & their global clinical studies. This role is based at our site 007 - UK - Chorley working within the IHE (In-House Engineering) workshop. The post holder will provide a comprehensive clinical trial value-added equipment service including: commissioning maintenance calibration repair management services technical support This element of work will be working hands-on to support a wide range of clinical specialties, whilst assisting with our business product lifecycle management. This role will further support our GSM in the continuous improvement of departmental processes, procedures and data quality including: (i) ISO 9001 QMS (Quality Management Systems) Including: SOP's (Standard Operating Procedures) WI's (Work Instructions) PF's (Process Flows) Incident & safety alert project management Management of engineer QMS IHE training records day to day (ii) RBS (Resonant Business Systems) IHE's continuous improvement efforts Acting in support of our GSM (Global Service Manager) in respect of QMS & RBS activities (on a global basis). How will you make an impact & Requirement In this role you will: IHE General Responsibilities: Perform a wide range of technical duties on complex clinical trial equipment ensuring optimum effectiveness, reliability, availability & safety. Demonstrated competency in the use of all applicable test equipment and tools required to perform the following duties for these equipment types (but not limited to): infusion systems (ambulatory, syringe and volumetric infusion pumps), patient monitoring equipment, diagnostic EKG's, ambulatory EKG's, Holter and stress systems, ophthalmic equipment, centrifuges, refrigeration equipment, point of care (POC) devices and haematology analysers. Knowledge of a wide range of sciences including, but not limited to, electronics (analogue and digital), computer science/networking, mechanical engineering design. Management of assigned shared mailboxes. IHE Global QMS Responsibilities: Provide leadership, comprehensive admin support & overall management of our IHE departmental QMS documentation, processes & procedures. Support our GSM, plus our sourcing business function, liaising with product & service business partners to obtain technical & commercial information under confidentiality agreements in relation to product maintenance, calibration, service & repair. Take the lead to propose changes to departmental technical & servicing procedures. Audit / review other team members jobs & ensure paperwork is completed & correct information is recorded within our company ERP system. Routine audit lead. Ensure that quality & performance targets are met. Communicate to individuals medical device information which will include policy changes, new policies, guidelines and regulations. Communicate sometimes unwelcome information regarding clinical technical issues, policy and service delivery issues with staff, suppliers and outside agencies many of whom may have opposing views. Communicate with suppliers and all external bodies as necessary. DMR (Discrepant Material) management / reporting. NCP (Non-Conforming Product) management. IHE RBS Responsibilities: Act as our IHE Global RBS project leadership in respect of capabilities, lean processes & tools that enable us to do it by leading / supporting associate-lead daily improvements via our kaizen philosophy about making tomorrow better than today. Help eliminate waste to increase value for stakeholders at the core to our continuous improvement. Ensure that team members keep their work benches, test bays & workshops clear, clean & tidy (at all times) - note: this is an integral part of our 6S activities in support of RBS. Demonstrate the ability to manage multiple priorities in a fast-paced environment while keeping customers' needs in mind. Management of defects. Analytical Judgement: To play a pivotal role in ensuring governance excellence in the use, training, maintenance and support of laboratory & medical devices. Analyse complex problems, situations and information, making informed judgments and formulating solutions and recommendations for the continual improvement of patient safety. Contribute to decisions/judgements involving situations where expertise in a field is required taking into account, health & safety and conflicting demands. General Skills: Results-oriented, energetic, self-motivated, and a dedicated team player. Proven problem solving and