Rosmee Wilson Aynikkal Email & Phone Number

Sydney, New South Wales, Australia

Australia

Develop and maintain Quality Management System according to compnay and local regulatory requirements, including establishment and implementation of SOPs, process improvements and records management.Initiate, monitor, and manage NCR, CAPA, SCAR and Product Risk Assessment (PRA) Process, including the required document preparation in a timely manner in collaboration with the cross-functional team.Manage and implement training on Quality Assurance Systems, policies, processes, procedures,… Show more Develop and maintain Quality Management System according to compnay and local regulatory requirements, including establishment and implementation of SOPs, process improvements and records management.Initiate, monitor, and manage NCR, CAPA, SCAR and Product Risk Assessment (PRA) Process, including the required document preparation in a timely manner in collaboration with the cross-functional team.Manage and implement training on Quality Assurance Systems, policies, processes, procedures, consistent with Edwards Global and local SOPs ensuring that the quality of products and services conform to established standards and regulatory requirements.Responsible for implementing and monitoring Quality metrics and providing inputs in Quarterly Management Review for ANZ to report on the performance of the quality system to Management with executive responsibility for review and any need for improvement.Respond to internal customers data requests to support process investigations and improvements.Performing and support of Internal, Corporate and External audits to ensure continued compliance per ISO13485, ISO 9001, and applicable regulatory requirements.Respond to external/internal auditors or inspections to Quality Management System.Implement and manage Supplier and Distributor management via the performance of supplier and distributor audits while ensuring evaluation, approval, and control of suppliers in ANZ.Drive improvement for 3PLs and Suppliers Quality Management System, implement and maintain Quality Agreements.Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods and Returned Products.Implement and track Quality Holds and Quality release coordinating with local ANZ business and 3PLs. Show less

Sydney, Australia

Ensure the release of high quality products from manufacturing, which comply with specifications and regulatory requirementsEnsure the appropriate levels of process controls, monitoring plans and reaction plans are in place via the Manufacturing Quality PlanDrive the performance metrics for non-conformances, and provide status update reports for CAPAs, audit findings, acceptance/release activities and process monitoring activitiesEnsure the Quality Operations team are active in… Show more Ensure the release of high quality products from manufacturing, which comply with specifications and regulatory requirementsEnsure the appropriate levels of process controls, monitoring plans and reaction plans are in place via the Manufacturing Quality PlanDrive the performance metrics for non-conformances, and provide status update reports for CAPAs, audit findings, acceptance/release activities and process monitoring activitiesEnsure the Quality Operations team are active in checking, identifying and ensuring all quality operational processes in manufacturing are compliant to relevant standardsDevelop and apply testing processes for new and existing products to meet client needsResponsible for the closure of Non-conformance, NCRsCollaborate with key stakeholders, Liaise with internal teams as the quality subject matter expertCreating and maintaining company documentation, such as quality manuals, and quality procedures.Troubleshooting problems or flaws in the item provided for testing.Meeting with members of the production team to offer recommendations and share results.Maintaining and controlling calibration records for all test and inspection equipment.Performing tests and measurements using existing measurement equipment. Show less

Westmead, Nsw

•Provide technical support in order to provide the highest healthcare quality to medical equipment and any other diagnostic or treatment technologies (including medical gas) in the hospital in accordance with Australian and international standards.. •Liaise between hospitals and major medical technology suppliers and vendors in order to ensure best deals with highest quality and latest technology and to ensure the match between clinical demands and medical technologies produced… Show more •Provide technical support in order to provide the highest healthcare quality to medical equipment and any other diagnostic or treatment technologies (including medical gas) in the hospital in accordance with Australian and international standards.. •Liaise between hospitals and major medical technology suppliers and vendors in order to ensure best deals with highest quality and latest technology and to ensure the match between clinical demands and medical technologies produced. •Directing and performing preventative and corrective maintenance and troubleshooting of medical equipment, include but not limited to: Monitoring systems, Infusion Devices, operational theaters systems and equipment…etc. •Providing data and reports to prepare full monthly report to the hospitals about the conditions and the performance of medical equipment and technologies in the hospital in order to make decisions in relation to: upgrading, decommissioning or maintaining medical equipment.•Installation and commissioning of medical treatment areas and biomedical equipment in the hospital accordance with Australian and international standards•Experience in repairs and service of electro-medical equipment including Electro-surgery Units, Defibrillators, Endoscopic Equipment, Infusion Devices, Various Pumps, Tympanic Thermometers.Patient Monitoring,Body/Cardiac protected electrical areas.•Anaesthetic Equipment including Anesthetic Machines, Ventilators and Vaporisers;Gas Therapy Equipment including medical gas regulators, flow-meters and suction equipment.•Writing reports and documentation for senior management,Service log entry of daily activities in HP- Service Manager.SC- Mobile for offline data entry during department visits.•Repair, maintenance and calibration of medical equipment, provided in line with Australian Standards, in particular AS/NZS 3551:2012•Patient Treatment Area testing to AS/NZS 3003:2011•Medical Gas Systems Testing to standard AS 2896:2011 Show less

India

Perform case study on various diabetic Retinopathic patients.Obtained fundus images using VISUCAM 500 – ZEISS of the patients.Good understanding of equipment’s used in eye care.Liaising with technicians and manufacturers to ensure the feasibility of a product in terms of design and economic viability.Evaluate the safety, efficiency, and effectiveness of biomedical equipment.This work is aimed to develop an automated system to analyse the retinal images for extracting… Show more Perform case study on various diabetic Retinopathic patients.Obtained fundus images using VISUCAM 500 – ZEISS of the patients.Good understanding of equipment’s used in eye care.Liaising with technicians and manufacturers to ensure the feasibility of a product in terms of design and economic viability.Evaluate the safety, efficiency, and effectiveness of biomedical equipment.This work is aimed to develop an automated system to analyse the retinal images for extracting important features of diabetic retinopathy using the image processing techniques. Automatic detection of retinal blood vessels is necessary for automated detection of DR. The proposed work uses an Extreme Learning Machine (ELM) approach for blood vessel detection in digital retinal images. This approach is based on pixel classification using a 7-D feature vector obtained from pre-processed retinal images and given as input to an ELM. Classification results categorizes each pixel into two classes namely vessel and non-vessel. Data base images are trained using Probabilistic Neural Network . Position of abnormality in the image is found by segmentation based on ELM approach. Performance analysis is done by calculating Mean square error and Peak signal to noise ratio of the retinal image. Role : Was responsible for developing idea, Analysis , study and Implementation. Show less

Bengaluru Area, India

Assisted Researchers in the college to carry out Defence Research & Development Organization (DRDO) projects.Responsible for the overall management of Linear Integrated Circuits lab.Working across a diverse range of research tools and equipment.Worked with professors on long-term lab planning and assignment of students to lab duties.Responsible for maintaining an up to date inventory of the lab’s equipment.

Kerala,India.

Was in charge for Electronics Lab, Biomedical Equipment Lab.Carried out Calicut University Examination paper evaluation of LIC, BT. Committee in charge for Med Con - 2008 , All India Technical symposium, where I was primarily responsible for Paper Presentation event and was also member of Finance Committee

Kerala,India

Outlined new materials, devices and equipment with Experience in the cost effective sourcing of third party suppliers of parts and servicesCoordinated with technicians, manufacturers and medical professionals.Handled technical queries and checked clinical equipment and coached technical staff.Communicating with clients on a prompt, understandable level.Prioritizing workload based upon medical urgency.Identified reliable medical apparatus suppliers and Evaluated bio-medical… Show more Outlined new materials, devices and equipment with Experience in the cost effective sourcing of third party suppliers of parts and servicesCoordinated with technicians, manufacturers and medical professionals.Handled technical queries and checked clinical equipment and coached technical staff.Communicating with clients on a prompt, understandable level.Prioritizing workload based upon medical urgency.Identified reliable medical apparatus suppliers and Evaluated bio-medical equipment accurately. Supervised on time delivery and ensured the equipment’s are installed properly and Maintained bio-medical equipment in the hospital.Install, adjust, maintain, and/or repair biomedical equipment. Show less

Master'S Degree, Applied Electronics

Activities and Societies: Paper Presentations at international and national conferences.

Bachelor'S Degree, Biomedical/Medical Engineering

Activities and Societies: Engineering Biomedical Students Association [EBSA] Project : Infant Care Telemetry system . Paper presentation.