Zahid Ramzan
Hodge Hill,Birmingham
Overview
26
26
years of professional experience
Work history
Quality Specialist
BlueDop Medical
02.2024 - 08.2025
- Duties include overseeing and maintaining the day-to-day requirements of the Quality System and Quality Assurance in relation to business activities.
- Create workflows, processes, and procedures and design company-specific tools to enhance efficiency and accuracy in completing business and operational tasks.
- MDD to MDR transition recommendation from BSI.
- The Quality Specialist supports and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
- Monitor, maintenance and optimisation of existing processes and creation of new processes, procedures and instructions.
- Maintenance of technical files and test reports of product conformity according to MDR Regulation (EU) 2017/745 and MDD 93/42/EEC and amendments 2007 (be aware of the latest regulation), FDA requirements, UK requirements and other global regulations.
- FDA 510K approval process for BlueDop Medical Vascular Expert.
- Implementation of Cyber Security at BlueDop Medical to conform with ISO 27001.
- Lead R&D with IQ, OQ, and PQ for new device BlueDop Medical Vascular Expert 2.0.
- Review and update Software documentation to ISO/IEC 62304 for BlueDop Medical Vascular Expert 2.0.
- Support processing and tracking NCR and CAPA activities.
- Supports preparation and execution of Notified Body audits and prepare reports.
- Support preparation of technical files for compliance to global regulations.
- Support internal and external audits.
- Assist in investigating quality issues, interact with Suppliers.
- Review and investigate customer complaints.
- Subject matter expert for root cause process.
- Support ensuring quality requirements are embedded, understood and applied throughout the organisation on all levels.
- Partners with subject matter experts to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data, and other documented requirements for quality objectives.
- Review and approve product-related study protocols, data, records, and reports.
- Support production of products to ensure manufacturing and release are performed in accordance with applicable company procedures and comply with all applicable regulatory requirements.
- Support QA approvals for change notices, test methods, and test equipment to ensure the design and production of products comply with applicable standards.
QARA Manager
Combat Medical Limited
10.2022 - 01.2024
- Company Overview: UK Operation Combat Medical Ltd (CML), which is part of Combat Medical Group.
- Be the management representative responsible for the effective implementation of the Quality Management System and Regulatory requirements for all relevant medical devices manufactured by the business while working closely with the Group Head of RAQA to ensure the implementation of the common group corporate QMS & Regulatory strategy across the group.
- Act as the primary point of contact for the business with respect to Certification and notified bodies for audits assist in dealings with National Health Competent Authorities and support the maintenance of Technical Files, Design Dossiers, and Device Master Records, including certification and all other important documentation for the business product portfolio.
- As Management Representative ensure Management Reviews, CAPAs, and Complaints are undertaken as per planned arrangements.
- Ensure the requirements of the Group QMS and Risk Management programs are implemented effectively at CML.
- To provide quality assurance support to the R&D, Operations, and commercial teams, agreeing on priorities and conveying project timelines, risks, and opportunities.
- To ensure the technical documentation, design history records, and device master records are in a permanent state of audit/inspection readiness for all relevant jurisdictions where CML products are marketed.
- To plan and coordinate internal and external audits with accredited bodies and customers as required.
- Supplier approval and supplier review with the use of risk management.
- Audit of critical suppliers to ISO 13485, ISO 14971, FDA CFR 820 ISO/IEC 62304 and ISO 9001 within the UK, EU, and global.
- Monitor NCRs from internal and external audits for root cause analysis, corrective actions, and preventative actions.
- Supplier performance monitoring, implementing trend analysis On-time in full (OTIF), SCARs, and reporting to senior management.
- Communicated with suppliers to implement corrective and preventative actions, root cause analysis, and drawings and manufacturing transfer documentation updates.
- Review Supplier technical drawings, qualification reports, manufacturing transfer templates, and approval to sign off.
- Review of supplier documents such as DOC, DEHP, Packaging Specifications, and validation documents.
- Maintain all Combat Medical internal NCRs, CAPAs and SCARs.
- To assist the Head of RAQA in the registration of products to meet business requirements.
- To provide input to critical metrics and management reports.
- To provide appropriate input to budget and forecast development.
- To ensure the established QMS is implemented and maintained effectively, and all certifications are maintained.
- Overseas update to CML and Biosurgical S.L QMS rewrite from 2003 to ISO 13485:2016.
- Implementation of a new device for the treatment of peritoneal cancers L∞P and Bubbler from R&D, Validation, Clinical trials, and evaluation.
- Lead R&D with IQ, OQ, and PQ for new devices L∞P and Bubbler.
- Registrations of CML products across EU and world markets such as Spain, France, Lithuania, Ukraine, Ecuador, Mexico, Australia, Brazil, Israel, India, Taiwan, and UAE.
- Post-market surveillance and PMCF, PSUR awareness, and PMS reports were produced for devices and consumables.
- Assessment of Technical File submissions against requirements of the Medical Device Directive and relevant harmonised standards for Class I (m) & (s) IIa, IIb, and Class III active and non-active devices.
- CML transition from MDD to MDR with BSI.
- Risk file review and update to ISO 14971:2019 for CML devices and consumables.
- CML’s Person Responsible for Regulatory Compliance (PRRC) specifically for the final review and release of CML products.
- People management experience, managing quality engineer.
- Good knowledge of European, Canadian, and US Medical device regulations. Broad awareness of Australian and Japanese regulations. Good knowledge of forthcoming EU MDR & IVDR.
- Certification Decision maker regarding EC certification against current MDD requirements (New registrations, Scope Expansions, extensions, Suspensions, and Withdrawals) based on a review of Technical Documentation and Audit assessments.
- Set up and implemented both Quality Management Systems to address regulatory requirements (to ISO 9001/ISO 13485 to meet requirements of European, Canadian, and US Medical device regulations) and Environmental Management Systems (to ISO 14001).
- UK Operation Combat Medical Ltd (CML), which is part of Combat Medical Group.
Quality Engineer
Quanta Dialysis Technologies
06.2020 - 10.2022
- Trained to ISO 13485, ISO 9001, ISO 14001, ISO 14644-1, Regulation (EU) 2017/745 and FDA 21 CFR 820.
- Medical Device experience Class I, Class IIa, Class IIb, and Class III.
- Awareness in Risk Management EN ISO 14971 and applying this during NCRs, CAPAs, and Complaints.
- To ensure the Quality Management System (QMS) at Quanta Dialysis meets all current Regulatory requirements relevant to our business by conducting internal and external audits, acting on any NCRs found, and reporting the findings.
- Led customer feedback and complaints triage meetings and responded to feedback from Hospitals and Home patients, raising nonconformities and complaint investigations.
- Knowledge of using methods FMEA, pFMEA, and Control Plans.
- Management of internal audits within the overall program to ISO 13485, ISO 9001, and FDA 21 CFR 820. Ensuring that audits are conducted as planned and that NCRs and CAPAs are documented.
- Supplier approval, monitoring, and scoring of suppliers to record as critical to business, reviewing data to contribute to the supplier management program.
- Auditing of critical Suppliers to ISO 13485, ISO 9001, and FDA 21 CFR 820 requirements.
- Leading CAPAs agreeing to corrective and preventative action with departments, conducting root cause analysis ISHIKAWA DIAGRAM, The 5 Whys, Failure Mode, and Effects Analysis.
- Ensuring Change Requests, and deviations meet the standard requirements and risk analysis conducted.
- Advising appropriate corrective action to take when NCRs raised in complaints are documented and ensuring that any action required is taken on time.
- Ensuring that internal audits are conducted as planned and that NCRs and CAPAs are documented and recorded on eQMS.
- Carried out QMS document updates, reviews, and approval.
- EQMS implementation and migration for the company across two sites.
- Ensuring that all work undertaken is documented and can be followed by external auditors and regulatory bodies.
- Highlight trends in reported incidents from complaint/feedback to necessary departments and follow up on corrective actions.
- People management experience, managing quality engineers and QA Administrator.
QA Specialist
Ascertain Forensics
07.2019 - 06.2020
- Support activities to ensure the Quality Management Systems are maintained in line with ISO 17025:2017, ISO 17020, Forensic Science Providers: Codes of Practice and Conduct, 2017, and Human Tissue Authority.
- Support external audit activities targeting no major findings.
- Support and monitor thorough and effective non-conformance management practices within the laboratory.
- Manage document and change management processes and support internal audit process.
- Monthly reporting of relevant laboratory quality metrics and trend reviews of key quality processes for the laboratory.
- Monthly reporting of relevant quality metrics including open quality items and laboratory sample TAT.
- Provide training to all members of staff, as required ensuring they are fully trained and have knowledge of Quality Management System principles, Good Laboratory Practice, Good Document Practice, CAPA, and Root Cause Analysis.
- Conduct and report internal and external proficiency schemes.
- Support the wider QARA team in routine activities and new initiatives.
QA – Audit and Supplier Monitoring
The Binding Site
10.2017 - 07.2019
- Company Overview: IVD, IVDr UVDR
- Awareness of IVDr regulations and submissions working with the company testing myeloma cancer and medical devices used for testing myeloma via Microbiology and HPLC testing.
- Trained to ISO 13485, ISO 9001, ISO 14001, FDA 820 and MDSAP.
- Managed team to carry out internal audit schedule and external audit schedule.
- Supplier approval, monitoring, and scoring of suppliers to record as critical to business, reviewing data to contribute to the supplier management program.
- Auditing of critical Suppliers to ISO 13485, ISO 9001, and FDA 21 CFR 820 requirements.
- Provide technical advice to operations and quality to develop and validate (IQ, OQ, PQ) manufacturing processes for medical devices that have been highlighted during auditing internally and externally.
- Leading Internal Audit CAPAs agreeing to corrective and preventative action with departments, conducting root cause analysis ISHIKAWA DIAGRAM, The 5 Whys, Failure Mode, and Effects Analysis.
- To ensure that The Binding Site Suppliers management system meets all regulatory and business requirements, and that supplier qualification, audits, and monitoring are appropriate for the products that they supply.
- Management of Supplier Corrective Action Reports (SCAR) and reporting trends to management.
- Management of specific internal audits within the overall program. Ensuring that audits are conducted as planned and that NCRs and CAPAs are documented.
- Following up on internal audit CAPAs agreeing to corrective and preventative action with departments and reporting these to the QSRM.
- Advising appropriate corrective action to take when NCRs are documented and ensuring that any action required is taken on time.
- Ensuring that all work undertaken is documented and can be followed by external auditors and regulatory bodies.
- Ensuring that all NCRs, SCAR, and CAPA are followed up once external audits are completed and reporting the findings back on time.
- Reporting to QSRM the number of NCRs & CAPAs and any that are still outstanding and presenting statistical data reports to the QSRM.
- IVD, IVDr UVDR
Quality Assurance Officer
Cattle Information Service
07.2017 - 09.2017
- Company Overview: Food
- Microbiology auditing to ISO 4833 - 2:2013 and ISO 15189:2012.
- Microbiology auditing to UKAS standards for BVD, John's Disease M Paratuberculosis, and Mastitis.
- Auditing to UKAS ISO 17025:2005.
- Food
Quality Assurance Analyst
National Milk Laboratory
01.2012 - 07.2017
- Company Overview: Food
- Microbiology auditing to ISO 4833 - 2:2013 and ISO 15189:2012.
- Microbiology auditing to UKAS standards for BVD, John's Disease M Paratuberculosis, and Mastitis.
- Auditing to UKAS ISO 17025:2005.
- Food
Forensic DNA Analyst/Technical Support
Forensic Science Service
01.2000 - 03.2012
- Involved in projects such as the set-up of Hamilton Robotics, Qiagen EZ1 to provide an alternative 9 Hour processing method of DNA, for the first in the UK, and implementing the Business Quality Model (BQM) to help improve productivity and quality in the DNA processing line.
- Rewarded for both projects with the Going Extra Mile (GEM) award as recognition for challenging work.
- Consistently accomplished 100% in monthly Key Performance Indicators for instrumentation calibrations supporting the DNA processing line.
- Consistently meet service level agreements (SLA).
Timeline
Quality Specialist
BlueDop Medical
02.2024 - 08.2025
QARA Manager
Combat Medical Limited
10.2022 - 01.2024
Quality Engineer
Quanta Dialysis Technologies
06.2020 - 10.2022
QA Specialist
Ascertain Forensics
07.2019 - 06.2020
QA – Audit and Supplier Monitoring
The Binding Site
10.2017 - 07.2019
Quality Assurance Officer
Cattle Information Service
07.2017 - 09.2017
Quality Assurance Analyst
National Milk Laboratory
01.2012 - 07.2017
Forensic DNA Analyst/Technical Support
Forensic Science Service
01.2000 - 03.2012
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