In House Engineering Quality & Continuous Improvement Lead & Service Engineer in Chorley

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:

• 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
• 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).

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.

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.

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 leadership skills.
• Exhibits initiative, attention to details and follow through.
• Ability to learn industry regulations and Resonant’s proprietary systems.
• Committed to the highest standards of customer satisfaction and providing the ultimate customer experience.
• Excellent knowledge of Microsoft Office Suite; experience working with other computer applications (such as databases) with an aptitude to further develop technical skills preferred.
• Excellent verbal, written skills in addition to presentation and interpersonal communication skills.

Account Management:

• Build and maintain internal and external customer relationships.
• Adhere to Mission, Vision, and Values of our organization.
• Provide a positive representation of Resonant Clinical Solutions by integrating core values into job performance.

Technical Support:

• Research technical documents, reviews product specification and utilize resources such as technical monographs, company R&D experts, in-house databases, and personal technical background to communicate information to internal & external IHE customers.
• Triage and resolves internal / external customers’ technical issues related to quality, applications, products, and delivery systems.
• Participate in designing/improving information collection, documentation and archiving processes with other departments including but not limited to Marketing, Sales, Operations and Quality Assurance.
• Participate as part of cross functional team associated with the customer intimacy programs; responsibilities may include project management, data collection and review, hosting and participating in recurring meetings, and issuing meeting minutes.
• Perform other duties as assigned with or without accommodation.
• Respond to customers’ complex technical inquiries (via telephone, email, and live chat) pertaining to the company’s product lines.
• Responsible for cleaning and disinfecting routine, cleans, sanitizes and maintains records associated with each serialized equipment record to abide by all regulations.
• Assist with IHE inventory receipts and inventory counts.

In-House Engineering:

• Inform management / other stakeholders of the status of repairs, scheduled inspections, unusual situations and any customer concerns.
• Work with, direct and document the activities of subcontractors / outside services whilst working on-site in Chorley UK.
• Maintain expertise through ongoing training and education. Also, must be willing to travel for training opportunities domestically and internationally.
• Responsible for ensuring all service documentation is completed, timely and accurately by maintaining the accuracy and integrity of the company ERP system to include the following: inventory, service history, documented results and relevant transactions.
• Respond to Medical Equipment Recalls and Alerts as directed by GSM & Corporate QA.
• Assist with special projects as assigned.
• Will assist in training of new IHE trainees and apprentices.

Biomedical:

• Perform routine maintenance and calibration on biomedical equipment.
• Repair and troubleshoot malfunctioning devices.
• Conduct safety tests to ensure compliance with healthcare standards.
• Document all maintenance and repair activities.
• Collaborate with manufacturers for advanced troubleshooting.
• Assess equipment for upgrades or replacements.
• Maintain an inventory of spare parts and tools.
• Ensure all equipment meets regulatory and accreditation standards.
• Assist in the evaluation of new medical devices.
• Update technical knowledge through ongoing education and training.
• Develop and implement preventive maintenance schedules.
• Keep abreast of new technologies and industry best practices.

Qualifications:

• BTECH HNC / HND or relevant level of experience in an appropriate engineering field.
• Minimum of five (5) years technical services, engineering, quality experience required.
• Project management experience is highly preferred.
• Experience & certification in the following product area is highly desired: Laboratory products (refrigeration, centrifuges, incubators etc.), Medical Devices, Infusion systems (ambulatory, syringe & volumetric infusion pumps).

Knowledge Skills and Abilities:

• Evidence of continued professional development e.g. attendance at training courses (manufacturer & specialist).
• Experience of QMS: ISO 9001.
• Knowledge of relevant legislation, technical & quality national / global standards.
• Understanding of the risks to patients & staff arising from the use of a wider range of laboratory / medical products.
• Electrical / electronic experience.
• Knowledge of the operation & maintenance of medical / laboratory products.
• Ability to organise own workload.
• Ability to work without supervision using own initiative on low, medium & high-risk medical equipment.
• Good communicator orally and written.
• Understanding of clinical measurements / procedures.
• Physically fit to undertake tasks involving frequently lifting & moving equipment.
• Create & maintain effective professional relationships.
• Responsive & flexible attitude & approach.

Desirable:

• Experience of ISO 17025 / ISO 13485.
• Planned maintenance of: Infusion Pumps.
• Supervisory experience.
• Experience within an EBME or OEM or Commercial department or equivalent.
• Experience of MS Office 365.

General:

• Experience with a wide range of medical equipment.
• Strong analytical and problem-solving skills.
• Proficiency with diagnostic software and tools.
• Excellent communication and interpersonal skills.
• Ability to work under pressure and handle emergencies.
• Knowledge of healthcare regulations and standards.
• Prior experience in an engineering workshop setting.
• Proficiency in reading and interpreting technical manuals.
• High school diploma or equivalent.
• Technical training in biomedical equipment technology.
• Strong understanding of electronics and mechanical systems.
• Ability to read and interpret engineering schematics.
• Detail-oriented with strong organizational skills.
• Basic computer skills, including proficiency with MS Office.
• Ability to work independently and as part of a team.
• Willingness to continually update technical skills.

Environmental Working Conditions & Physical Effort:

• Physical ability to lift and move equipment.
• May need to lift equipment, parts, or boxes weighing up to 25 Kg.
• Good hand and finger dexterity to use hand tools and work with small components.
• A moderate level of physical effort in their work. This includes lifting, bending, walking, and standing for extended periods, as well as some exposure to potential hazards.