Kunaal Ramful
Quality Compliance Manager at Olympus Medical UKIE- Claim this Profile
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Creoles and pidgins, French-based -
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Bio
Credentials
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IRCA Certified ISO 9001 & ISO 13485 Lead Auditor
IRCA GlobalOct, 2015- Oct, 2024
Experience
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Olympus Medical UKIE
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United Kingdom
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Medical Devices
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1 - 100 Employee
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Quality Compliance Manager
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May 2017 - Present
Responsible for qms within the Olympus UI group including Ireland, Bolton, Southend and supporting a site in Plymouth. Project lead for bringing all 4 quality management systems into a single framework. Working within EMEA working group to harmonise QMS across the region and draft EMEA processesCurrently also covering quality engineering manager position for production and R&D activities (temporary).Nominated for most significant contribution to the manufacturing business in 2020Won award for significant contribution to support and development in 2018Nominated for most significant contribution to the manufacturing business in 2017Key achievement - project lead for transitioning to ISO 9001:2015, ISO 13485:2016, AND MDSAP requirements, certification was achieved in March of 2018.Manager of a team 9, multidisciplinary QARA team with overall responsibility for complaint handling, vigilance reporting, FSCA, data analysis, CAPA, document and record control, supplier quality and internal audit.- responsible for the quality management system- preparing and managing external 3rd party audits (BSI)- Ensuring the business remains compliant to regulatory changes- deputy for management with executive responsibility.
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Quality Auditor
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May 2015 - May 2017
- Audit all QMS processes accordingly to ISO 13485, ISO 9001, FDA 21 CFR Part 820, 806 and 803, CAMDAS 13485 and MHLW Ordinance 169.- Lead auditor qualified to IRCA ISO 9001 and ISO 13485, internally trained auditor to MHLW Ordinance 169.- Internal audit of all QMS related processes and audit of high risk suppliers according to product specification / Quality agreement.- Issuance of non-conformance reports, effectiveness check and trending of data NC data.- Encouraged continuous improvement activities through recommendations for improvement- Responsible for managing implementation of global complaint handling system for Olympus UK manufacturing division- Preparation and successful execution for FDA and ISO 13485/ISO 9001 re-certification audit- Project lead for gap analysis and implementation of required updates to QMS in order to meet compliance to ISO 9001:2015 and ISO 13485:2016 (note project timescale is from March 2016 – March 2018)
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Philips
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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QARA Engineer
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Jan 2014 - May 2015
- Management and creation of technical file for Class IIa devices, including risk management, clinical data review, biocompatibility and essential requirements checklist.- Point of contact for regulatory support in the design and development of compressor (Nebulizer) products (60601-1-1, 1-2, 1-6 & 1-11) and reviewed/approved for any documentation.- Reported adverse events to regulatory authorities including US FDA and European MIR reports.- Supported registration requirements for devices within North and South American markets.- Initiated design changes which is instigated from analysing complaint data. - Raised SCAR and CAPA reports, Supported QMS review meetings, management of QMS, Internal audits and external audits.
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Compliance Officer
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Sep 2013 - Nov 2013
- Conducting risk management for key company projects to ISO 14971 (FMEA)- Review of project documentation to ISO 60601 and 62304.- Participate in team meetings and providing regulatory support and advice- Organise and conduct companywide training on key company procedures and policies- Supported service management activities including post market surveillance reporting.- Creation of new CAPA system and update of process documentation- Management of deviation/concessions and notification of their expiry.
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Compliance Assistant
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Aug 2012 - Sep 2013
- Managing CAPA reports, assessing route cause analysis (FTA, 8D’s,5 Whys) ensuring requirements are met and verified, reporting on CAPA closure to senior management within the QMS management review meetings.- Creating quarterly QMS Management Review report for review in senior management meetings.- Managing Calibration equipment, ensuring they are quarantined, calibrated before the expiration date.- QMS monthly report, Reporting KPI’s to the management team on a monthly basis on Documentation, CAPA’s, Audits, Company training and Calibration equipment.- Managing the QMS system to ISO 13485, ISO 9001 and ISO 27001, Authoring and review of documentation.- Presentation of Induction training for new staff in key policies, including Ethical Practices, IT Security, Management of controlled documents and records, Change control, and supplier approval.- Planning and conducting audits to ISO 13485, FDA 21 CFR part 820, MDD Directive and all company policies and SOP’s.- Assisted in external audits and managing the closure of audit actions.- Creation and management of SharePoint sites, libraries, lists and pages for the entire company, implemented the automation of version and status of controlled documentation.
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Delta Controls LTD
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Automation Machinery Manufacturing
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Product Engineer
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Mar 2011 - Aug 2012
Currently in a graduate scheme in an ISO 9001 company with a successful completion in the procurement department. This role consisted of certification, Quality assurance and sourcing. This involved liaising with external bodies such as ATEX, BSI, UL, CSA, sourcing components internationally and key projects for the company.
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MONAD Precision Engineering
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United Kingdom
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Industrial Machinery Manufacturing
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1 - 100 Employee
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Quality Engineer
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Sep 2010 - Mar 2011
Worked within the Inspection department as well as gaining practical experience using CNC milling machines. Produced FAIR report and PCP reports for clients review.
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Education
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2005 - 2009
Kingston University
Mechanical Design Engineering, Mechanical Engineering -
1997 - 2002
Cheam High School
GCSE'S, Triple Science, maths, English, Geography, Business Studies, Systems & Control, IT, French
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