Vipin Abraham
Houghton Regis,United Kingdom
Summary
Eager to develop skills and contribute to the organisation through motivation, training, and teamwork. Committed to delivering best efforts in all endeavours.
Experienced professional with career focus in inspection and quality assurance. Capable of ensuring compliance with industry standards and regulations using thorough analytical skills and keen attention to detail. Committed to maintaining high levels of safety and operational excellence through diligent inspections and effective communication.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work history
Certification and Inspection Officer
NSAI
Houghton Regis, CBF
04.2025 - Current
- Improved compliance for active medical devices by reviewing mechanical design and safety documentation.
- Reduced safety and performance risk by validating documentation against relevant standards.
- Strengthened quality governance through internal audits across quality management system areas for NSAI
- Performed QMS based Technical file reviews for more than 100 files in relation to SaMD, Active Medical device codes.
EMEA Client Manager (Medical Devices)
British Standard Institute
Houghton Regis, Central Bedfordshire
11.2022 - 03.2025
- Conduct assessments in compliance with BSI requirements.
- Prepare and present assessment reports to clients, ensuring clarity on decisions and providing actionable corrective guidance when necessary.
- Recommend issuance, re-issuance, or withdrawal of certificates, adhering to BSI policies and timelines.
- Lead assessment teams as needed, briefing members to uphold service quality and maintain effective relationships with clients and within team.
- Provide accurate and timely information to support services, collaborating closely to ensure client records are current and all internal information requirements are fulfilled.
- Plan and schedule workloads to optimise time management and maximize revenue-generating activities.
- Coach colleagues, particularly inexperienced assessors or those unfamiliar with client operations, and assist in induction of new staff as required.
- Maintain and enhance assessment skills, as well as knowledge of technical and management system standards.
- Conducted total of 150 active medical audits, focusing on Software as a Medical Device, with emphasis on design and development, manufacturing operations, and core processes.
- Coordinated with internal teams to meet client expectations.
- Implemented strategies for better client retention rates.
Clinical Engineering Department Manager
Bedfordshire Hospitals NHS Foundation Trust
Luton
11.2020 - 08.2022
- Managed the Clinical Engineering Multi-Disciplinary team of Biomedical Engineers, delivering Clinical Technical Support across all aspects of Clinical Engineering, including preventative maintenance, inspection, repair, and calibration of critical medical equipment, ensuring compliance with departmental procedures, Trust policies, statutory regulations, and MHRA guidelines (Managing Medical Devices, April 2015 Edition).
- Implemented and annually reviewed ISO 13485/9001 QMS documents and flowcharts, driving improvements as needed.
- Supervised team workload, optimising member allocation to enhance productivity.
- Assisted the Trust’s Medical Devices Manager in reviewing and amending policies related to Healthcare Technology Management.
- Maintained service documentation in accordance with statutory regulations and guidance.
- Conducted annual appraisals for all staff, providing feedback and setting goals and objectives for the upcoming year.
- Escalated outcomes of all electro-medical incidents to the Medical Devices Manager and the MHRA when appropriate.
- Participated in regular meetings and acted on decisions made.
Theatre Equipment Manager
Bedfordshire Hospitals NHS Foundation Trust
Luton
11.2019 - 09.2020
- Managed the repair and maintenance of a portfolio of complex theatre and anaesthetic-related medical devices, specialising in advanced repair techniques and resolving challenging issues.
- Collaborated with various medical equipment companies on service contracts, complex repairs, and competitive pricing, achieving resource savings for the Department and Division.
- Led the response to equipment issues in theatres as they arose.
- Coordinated with the Trust’s EBME Department and Infection Control on all decontamination matters concerning new equipment purchases and current equipment maintenance.
- Provided technical advice to clinical staff during equipment use, including emergencies, throughout normal hours and during on-call periods.
- Contributed to the Trust’s capital bid process for theatre-related equipment acquisition.
- Supported the Procurement Team with equipment-related purchases and assisted the Procurement Lead during their absence.
- Aided the Head of Clinical Engineering in managing the performance of biomedical engineers and team members.
Senior Clinical Engineer / Theatre Equipment Engineer
Bedfordshire Hospitals NHS Trust
Luton
11.2014 - 11.2019
- While pursuing a Senior Engineer role, I gained comprehensive experience in the workflows and functionalities of the Medical Engineering Department and the National Health Service. My main objectives and daily responsibilities included:
- Overseeing the operational management of theatre equipment, including usage, preventative maintenance (PPM), and repairs.
- Conducting preventative maintenance, repairs, calibration, and acceptance testing of complex medical equipment.
- Investigating devices related to clinical incidents and producing detailed reports.
- Assisting in project management by supporting the Theatre Manager in procuring new medical equipment, raising PQO forms, and managing the extension of the Theatre Department, including commissioning, acceptance testing, and PPM of new equipment.
- Collaborating with clinical staff and suppliers to identify faults and repair a wide range of complex medical devices.
- Ensuring compliance with MHRA and OEM device safety notices/updates and communicating relevant information to clinical staff.
- Maintaining up-to-date COSHH (Control of Substances Hazardous to Health) records.
- Providing clinical technical services for the repair, servicing, calibration, and safety testing of all patient-connected medical electronic devices in accordance with DB2006(05) and MHRA guidelines.
- Keeping an accurate inventory of equipment, testing new devices, and maintaining records in the F2 database.
- Assigning PPMs, servicing, and calibration tasks to junior engineers and reviewing their monthly KPIs.
- Liaising with the Medicines and Healthcare Products Regulatory Agency regarding medical device incidents.
- Troubleshooting complex equipment connected to patients.
- Performing workshops and on-site repairs of complex medical devices using service manuals.
- Supervising external contractors and junior engineers during installation, commissioning, servicing, or repair activities.
- Ordering replacement parts for the repair and servicing of medical devices and managing stock levels.
- Overseeing the management of medical devices within the Trust, conducting audits, and evaluating new or loaned medical equipment.
- Responding to MHRA alerts and collaborating with healthcare professionals.
Education
Masters - Healthcare Management
University of Wales
London, United Kingdom 03.2011 - 04.2012
Masters - Biomedical Engineering
Fachhochschule Luebeck
Luebeck, Germany 03.2010 - 03.2011
B.TECH - Biomedical Engineering
Sathyabama University
Chennai, India 03.2004 - 04.2008
Skills
- Time Management: Expert
- Problem Solving: Expert
- Critical Thinking: Experienced
- Process improvement capabilities
- Regulatory reporting expertise
- Audit coordination capabilities
- Risk assessment techniques
- Quality assurance familiarity
Languages
Malayalam: B2
English: C1
Hindi: B2
Certification
ISO 13485 Certified
Medical Device Regulation Certified
Medical Device Single Audit Program Certified
14971 Risk Management Certified
Additional Information
Cricket Playing
Timeline
Certification and Inspection Officer
NSAI
04.2025 - Current
EMEA Client Manager (Medical Devices)
British Standard Institute
11.2022 - 03.2025
Clinical Engineering Department Manager
Bedfordshire Hospitals NHS Foundation Trust
11.2020 - 08.2022
Theatre Equipment Manager
Bedfordshire Hospitals NHS Foundation Trust
11.2019 - 09.2020
Senior Clinical Engineer / Theatre Equipment Engineer
Bedfordshire Hospitals NHS Trust
11.2014 - 11.2019
Masters - Healthcare Management
University of Wales
03.2011 - 04.2012
Masters - Biomedical Engineering
Fachhochschule Luebeck
03.2010 - 03.2011
B.TECH - Biomedical Engineering
Sathyabama University
03.2004 - 04.2008