Experience

Congenica

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Senior Quality and Regulatory Manager

  • Apr 2023 - 9 months

  Cambridge, England, United Kingdom Managed IVDR (EU MDR for IVDs) and ISO 13485 Certifications Audits and ISO 27001 Surveillance Audit. Answered IVDR Technical File Questions from Notified Body. Completed migration of QMS to Confluence Cloud.



Mirada Medical

• United Kingdom
• Software Development
• 1 - 100 Employee

• Head of QARA

  • May 2022 - Apr 2023

  Oxford, England, United Kingdom Lead a team of Quality and Regulatory professionals in a SaMD company. Worked on transition to MDR, movement to a new product operating environment and development of a global regulatory strategy (US, EU, Canada, China, Japan, South Korea, Australia, Brazil).



Oxford Immune Algorithmics

• United Kingdom
• Technology, Information and Internet
• 1 - 100 Employee

• Head Of Global Compliance

  • May 2021 - May 2022

  Leading the Regulatory, Compliance and Quality work for an award-winning AI company developing an immune monitoring platform and instrument. Achieved ISO 13485 certification within 8 months. Completed CE Certification of product to tight timeline. Advising Development Team and Regulatory, Compliance and Quality requirements. Establishing Compliance Team and developing team members.



Epredia

• United States
• Biotechnology Research
• 500 - 600 Employee

• Global Design & Compliance Lead

  • Oct 2020 - May 2021

  Developing and Implementing policies, reports and procedures for global regulatory compliance. Leading product development projects for Compliance, Risk Management, Verification and Validation functions.

• Quality Assurance Specialist

  • Jun 2019 - Oct 2020

  Runcorn, Cheshire, United Kingdom Advising, writing, reviewing and approving documents and work for cancer diagnostic medical devices: FDA 820 QSR Medical Devices Design Controls ISO 13485 (QMS) ISO 14971 (Risk Management) IEC 62304 (Software Development) IVDD (In Vitro Diagnostic Directive) IVDR (In Vitro Diagnostic Regulation) ISO 20417 (Labelling) ISO 18113 (Labelling) LVD (Low Voltage Directive) EMC (Electromagnetic Compatibility Directive) Verification and Validation Technical… Show more Advising, writing, reviewing and approving documents and work for cancer diagnostic medical devices: FDA 820 QSR Medical Devices Design Controls ISO 13485 (QMS) ISO 14971 (Risk Management) IEC 62304 (Software Development) IVDD (In Vitro Diagnostic Directive) IVDR (In Vitro Diagnostic Regulation) ISO 20417 (Labelling) ISO 18113 (Labelling) LVD (Low Voltage Directive) EMC (Electromagnetic Compatibility Directive) Verification and Validation Technical Files Design History Files (DHF) and Device Master Records (DMR) Internal and External Audits of procedures and DHFs. Process Owner and Process Improvement incorporating new and updated standards (e.g. ISO 14971:2019).



Surface Transforms Plc

• United Kingdom
• Motor Vehicle Manufacturing
• 1 - 100 Employee

• Senior Quality Engineer

  • Jul 2017 - May 2019

  Liverpool, United Kingdom Successfully implemented new Quality Management System, passing IATF 16949 certification audit in 7 months. Successfully implemented new Environmental Management System, passing ISO14001 certification audit in 3 months. Supporting suppliers in implementing IATF16949. Leading resolution of Non-Conformances through 8D methodology. Auditing internal processes (IATF16949, VDA 6.3, AS9100 D, ISO 9001:2015). IATF16949 Lead Auditor. Project managing continuous/continual improvement… Show more Successfully implemented new Quality Management System, passing IATF 16949 certification audit in 7 months. Successfully implemented new Environmental Management System, passing ISO14001 certification audit in 3 months. Supporting suppliers in implementing IATF16949. Leading resolution of Non-Conformances through 8D methodology. Auditing internal processes (IATF16949, VDA 6.3, AS9100 D, ISO 9001:2015). IATF16949 Lead Auditor. Project managing continuous/continual improvement projects. Providing support to APQP projects. Currently undergoing Lean Six Sigma Black Belt Training.

• Project Coordinator

  • Jan 2017 - Jul 2017

  Liverpool, United Kingdom Responsible for planning, co-coordinating and implementing projects for internal improvements, customer introduction and new product introduction. Working in/leading a cross-functional team to determine and deliver stakeholder requirements. Trained VDA 6.3 Process Auditor.

• Sales and Production Support

  • May 2015 - Jan 2017

  Ellesmere Port Achieved savings by process improvement: >£23,500/annum in furnace usage and shipping by reducing part sizes (Aug '16), ~£20,000 in recruitment costs by switching from recruitment agencies to CV Search Libraries for production staff. Negotiated savings with suppliers: ~£40,000 per annum by changing hardware supplier (Oct '15), £3,200/annum office costs (web hosting, furniture, stationery, telecomms), £2,500 in one-off web design fees (Mar '16). Administered sales orders and guide… Show more Achieved savings by process improvement: >£23,500/annum in furnace usage and shipping by reducing part sizes (Aug '16), ~£20,000 in recruitment costs by switching from recruitment agencies to CV Search Libraries for production staff. Negotiated savings with suppliers: ~£40,000 per annum by changing hardware supplier (Oct '15), £3,200/annum office costs (web hosting, furniture, stationery, telecomms), £2,500 in one-off web design fees (Mar '16). Administered sales orders and guide through contract review process. Trained as VDA 6.3 Process Auditor. Designed and maintained company website in English and German (www.surfacetransforms.com, surfacetransforms.de). Trained others in use of company website. Increased page views 167% over 18 months. Carried out market research for company expansion. Monitored production and prioritise orders to minimise customer delays. Built Sales Order Processing database, reducing administration time around 70% and increasing data availability. Helped manage a major production project for a new potential partner, including hand-delivery to Italy to meet deadline. Contributed to attaining Aerospace and Automotive Quality Standards. Investigated and Reconciled Customer and Supplier Accounts.



Oxford Cryosystems

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Customer Support Team Leader/Sales and Customer Service Executive

  • Nov 2012 - Apr 2015

  Oxford, United Kingdom Lead a team in technical support of scientific equipment. Produced technical documentation (manuals, tech notes, instruction videos). Trained customers and engineers in the use and installation of systems. Sold and marketed scientific equipment direct and through resellers worldwide. International Conference Attendance (as sponsor). International Sales Visits. Reduced repair turn around time 62% Reduced technical support turn around time 32% in nine months. Increased… Show more Lead a team in technical support of scientific equipment. Produced technical documentation (manuals, tech notes, instruction videos). Trained customers and engineers in the use and installation of systems. Sold and marketed scientific equipment direct and through resellers worldwide. International Conference Attendance (as sponsor). International Sales Visits. Reduced repair turn around time 62% Reduced technical support turn around time 32% in nine months. Increased sales in my targeted areas 16% in first year and 11% in second year. Created online helpdesk, writing over 100 technical support articles. Created and maintained departmental performance tracking system. Show less



Pulse Jobs

• United Kingdom
• Staffing and Recruiting
• 300 - 400 Employee

• Scientific Recruitment Consultant

  • Feb 2012 - Nov 2012

  Didcot, Oxfordshire Scientific recruitment - mainly temporary/contracted positions - across the South of England. Built relationships with 10 new active clients and maintained relationships with on-going clients. Used LinkedIn and other online research tools to identify and qualify potential clients. Created and maintained database of potential clients using temp workers. Negotiated and conformed to complex SLAs, including with local and national government.