In House Engineering Quality & Continuous Improvement Lead & Service Engineer

* 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.
* 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.
* 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
* 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)
* 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.
* Experience of ISO 17025 / ISO 13485.
* Planned maintenance of:
Infusion Pumps.
* Supervisory experience.
* Experience with in an EBME or OEM or Commercial department or equivalent.
* Experience of MS Office 365.
* 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.
*…