Experience

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  Osler Diagnostics

  • Oxfordshire, England, United Kingdom

  • Systems Risk Consultant

    • Nov 2023 - Present
    • Oxfordshire, England, United Kingdom

    - Team execution of point of care system risk identification, evaluation, mitigation- IVD medical device systems risk management documentation

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  ESPL Regulatory Consulting

  • Regulatory Affairs Consultant

    • Aug 2023 - Present

    Medical device specialist review & development of;- Regulatory roadmap, GSPR & clinical evaluation plan for SaMD medical device, FDA510k & CE - FDA 510k presubmission data pack & clinical evaluation plan for class 2 surgical equipment

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  Abbott Rapid Diagnostics Nordics

  • Oslo, Norway

  • Senior Quality Management Consultant

    • Oct 2022 - Jun 2023
    • Oslo, Norway

    • Retained to break CAPA/FCA/SCAR/QI logjam and transform team performance • Appraised staff, highlighted skills gaps, mentored team, shadowed, trained • Created formal CAPA teams and set up review programme to drive items through resolution process• Highlighted process shortcomings, worked hands on with teams to improve standard of output, rate improvement and audit readiness • Established trackers, prioritised and drove critical tasks, established real time compliance with group metrics. Drove down average age of CAPAs by ~70%.• Supported Notified Body audit, ran backroom, served as SME for CAPAs & QIs. Analysed audit findings, developed remedial actions and drove team to execute and close out• Established culture of excellence through displayed commitment to process, identification of continuous improvement actions, commitment to deliverables, timescales and information quality, hands on assistance with task execution • Secured first positive Quality metric achievement in the group’s history

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  Plexus Corp.

  • Livingston, Scotland, United Kingdom

  • Consultant, Quality Engineer

    • Nov 2020 - Apr 2023
    • Livingston, Scotland, United Kingdom

    Medical Device Quality lead on projects for Siemens, Medtronic, Ethicon, Smith & Nephew, ConvaTec, Biocartis, Biotronik, OriBiotech, Draeger, Titan Medical, etc. spanning laparoscopic surgery, wound management, thrombus aspiration, cardiac ablation, sterilisation process management etc

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  Abbott Rapid Diagnostics

  • Oslo, Norway

  • Consultant - QMS Remediation

    • Sep 2020 - Feb 2021
    • Oslo, Norway

    • Drafted in to accelerate remediation project to address audit nonconformities relating to IVD Medical Device sourcing, warehousing and distribution • Defined remediation actions and executed changes across multiple projects; cold chain shipping validation, product packaging & storage, warehouse controls, supplier management etc.

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  Abbott Diagnostics Business

  • Stirling

  • Consultant - China Remediation

    • Sep 2019 - Sep 2020
    • Stirling

    Lead compliance remediation programme for Abbott IVD medical devices distributed in China; • Assessed regulatory compliance requirements for 6 Legal Manufacturers of 49 class 2&3 medical devices against ~45 China regulations. • Established applicable clauses, conducted gap analysis, identified remedial actions• Recommended options to maximise ROI within remaining product life.

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  Plexus Corp.

  • Livingstone

  • Consultant, Quality Engineer

    • May 2018 - Dec 2019
    • Livingstone

    Consultancy support for Medical Device projects covering; - Wound Care, - Sterilisation Management, - Laparoscopic Surgery, - ElectrotherapyProject responsibility for various elements across;- Risk Management/Mitigation- Regulatory Compliance/Gap Analysis- Requirements Management- Verification Test Definition- Key DHF documentation; Inputs, Outputs

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  Abbott

  • Global Quality Consultant

    • Oct 2017 - Jan 2018

    Planned & executed programme to align IVD/medical device manufacturing sites in Americas, EMEA, APAC with Alere’s Global Quality Standards;• Onboarded 37 sites into Global Quality Framework; defined onboarding program, developed training material, delivered training, set up process to track monitor alignment to Global Standards.• Presented program to all sites at Global Quality Forums, established information requirements and site responsibilities.• Audited >200 site SOP’s encompassing medical device development, manufacturing, sales & distribution.• Reviewed alignment with standards, conducted gap analysis/compliance readiness reviews, compiled summary reports & presented to senior management.• Identified common trends, underperforming sites and poorly adopted processes, delivered one to one audit feedback to sites to close gaps

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  Alere Inc.

  • Global Quality Consultant

    • Aug 2017 - Sep 2017

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  Quanta Dialysis Technologies

  • United Kingdom
  • Medical Equipment Manufacturing
  • 200 - 300 Employee

  • Interim Director of Engineering

    • Aug 2014 - Mar 2016

    • Defined and built a 37 man development team; authored JDs, recruited, cascaded business goals to targets, conducted appraisals, reviewed and tracked team performance, adjusted team shape/scope/size.• Developed operational level plans to deliver programme through to UK launch and FDA 510(k) approval for US market. • Influenced Regulatory, Quality, Operations and Commercial colleagues to coordinate matrix activities across the business; Quality, Regulatory, Manufacturing strategy, outsourcing, commercial pathway, , volume scale up etc.• Represented Engineering in all aspects related to QMS, daily Quality Incident triage, identification of Corrective and Preventive Actions, SCARS etc. Reviewed and authorised all QI/CAPA/SCAR plans, root cause analysis etc.• Clinical pilot;o Collaborated in preparing clinical pilot plan.o Drove engineering team to prepare systems for first human patient use.o Coordinated analysis of clinical pilot system performance, risk analysis, design change, verification & release to clinic.o Drove engineering team to deliver 3 system updates in 6 months.o Drove team to complete clinical pilots across 3 clinical centres (>100 treatments, 100% reliability, no adverse events).• Compiled and delivered monthly engineering report to board of VC and corporate investors. • Compiled and delivered engineering reports to CEO at weekly management meeting. • Planned and managed engineering budget of £5.7m.

  • Technical Director

    • Aug 2009 - Jul 2014

    • Drove multidisciplinary team to develop complex dialysis technology from proof of concept demonstrator to CE approved product.• Planned and managed all programme activities including; regulatory compliance, risk management, requirements gathering, system development, integration testing, formal validation programme including Functional and Electrical safety, EMC, Sterilisation Compliance, Biocompatibility etc. • Defined & implemented issue management system and ran daily cross functional reviews of problem reports from lab testing and field complaints. Applied 8D, DMAIC, Ishikawa & 5whys analysis and drove engineering team to identify root cause, remedial actions, verification and effectiveness checks.• Led engineering team input during initial and surveillance audits with Notified Body (TUV Sud). • Identified poor performance of software & electronics outsource partners (inherited) and made case for internal capability. Defined and built in house software and electronic development teams; authored job descriptions, coordinated search, interviewed, secured team, performance measured, mentored. • Led R&D team via 5 direct engineering reports; systems, software, hardware, mechanical, innovation.• In Vivo testing;o Drove R&D team to produce devices and complete 3 rounds of in vivo (porcine) testing.• Established weekly reviews with CMO partners; triaged technical issues, procurement schedule, component, and assembly costs, cost down planning/volume scale up, EOL tests, process validation etc. • Managed planning of consumables manufacturing; design transfer, production process definition, CAPEX procurement, oversaw IQ/OQ/PQ validation, delivery of product, first article inspection, validation etc.

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  VitroNetics Ltd

  • United Kingdom

  • Director

    • Mar 2006 - Aug 2009
    • United Kingdom

    VitroNetics developed a unique blood sample preparation technology to allow hospital labs to process blood samples 10x more efficiently, and expedite urgent samples

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  Crombie Anderson

  • United Kingdom

  • Senior Consultant

    • Aug 1992 - Mar 2006
    • United Kingdom

    A hybrid life science development/consultancy group, my time was split between working on an in house medical device project (Optos) and external class 2 and 3 devices medical device projects spanning cardiovascular, laparoscopic surgery, diabetes management, gynaecology, orthopaedics etc