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Experience

    • United Kingdom
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Operations Director
      • Jan 2020 - 4 years

      Hever, Kent

    • Operations Director
      • Jan 2017 - Jan 2020

      Strong knowledge of ISO13485:2016, MDD 93/42/EEC, CMDCAS, ISO9001:2015 and ISO 14155 requirements Proven experience in implementing a Quality Management System for a medical device company Represent the Company at industry association policy and working group meetings HR responsibilities: Develop, implement and review HR policies, procedures and processes to ensure compliance with current employment legislation; Provide comprehensive HR and employment law advice to senior… Show more Strong knowledge of ISO13485:2016, MDD 93/42/EEC, CMDCAS, ISO9001:2015 and ISO 14155 requirements Proven experience in implementing a Quality Management System for a medical device company Represent the Company at industry association policy and working group meetings HR responsibilities: Develop, implement and review HR policies, procedures and processes to ensure compliance with current employment legislation; Provide comprehensive HR and employment law advice to senior management, line managers and employees ; Manage HR processes meet recruitment, selection, training, succession and retention requirements; Manage personnel records: holidays, absence, recruitment, inductions, contracts of employment etc; Manage relationships with Company Benefit providers; Demonstrate and lead positively the culture and positive ways of working; Develop and implement operational processes designed to achieve strategic fit and deliver results set out by the Directors and Management in the business plan; Maintain Health & Safety standards; Regulatory Compliance responsibilities: Managing the manufacturing projects for a Class IIa medical device, liaising with various international suppliers, ensuring the project is appropriately executed and documented; Maintaining the Quality Management System in accordance with ISO 13485:2016 and CMDCAS quality standards; Keeping up to date with changes in regulatory legislation and guidelines; Manage all technical file documentation required for ISO 13485:2016 and CMDCAS regulatory approvals; Drive QA knowledge across the business and train staff on QMS requirements; Participate in design processes to ensure compliance; Planning and carrying out internal audits of the QMS; Develop and maintain relationships with Notified Bodies, suppliers, consultants and distributors and undertaking site audits where required; Reporting QMS performance to senior management; Recording and reporting post market surveillance and vigilance activities.

    • Office Manager
      • Apr 2009 - Dec 2016

      Westerham, Kent Human Resource Management Responsible for all day to day HR activities and the employment lifecycle including: Creating, implementing and developing HR policies and procedures Providing advice and guidance to managers and employees on company policies, procedures and employment legislation. Supporting the implementation and delivery of key HR initiatives Supporting the development and engagement of employees Office Management: Property maintenance, utilities, Health and… Show more Human Resource Management Responsible for all day to day HR activities and the employment lifecycle including: Creating, implementing and developing HR policies and procedures Providing advice and guidance to managers and employees on company policies, procedures and employment legislation. Supporting the implementation and delivery of key HR initiatives Supporting the development and engagement of employees Office Management: Property maintenance, utilities, Health and Safety, data control, internal intranet. Line Manager to to the office team. Quality and Regulatory: Maintaining ISO 9001, ISO 13485 and MDD 93/42/EEC accreditation. Training staff on QMS requirements. Working cross functionally with the Production department to ensure devices are manufactured to the necessary quality requirements. Procurement: reviewing supply chain practices in accordance with new or changing environmental policies, standards, regulations, or laws. Monitoring supply chain activities to assess ability to meet quality and delivery requirements. Monitoring forecasts to identify and manage any changes to supply chain activities. Organising the planning, application and management of new and existing healthcare tenders.

    • United Kingdom
    • Capital Markets
    • Team Secretary
      • Jul 2008 - Mar 2009

      Southborough, Tunbridge Wells Secretarial Duties supporting a Team of Mechanical, Electrical and Public Health Engineers

    • United Kingdom
    • Law Practice
    • 200 - 300 Employee
    • IT Template Administrator
      • Jul 2007 - Jun 2008

      Tunbridge Wells Responsible for management of IT templates for legal information leaflets, Legal Oyez forms, DSE Assessments.

    • PA to the Sales and Marketing Director
      • May 2006 - Jul 2007

      Paddock Wood, Kent Support Director is all aspects of administration Liaise with Clients and Regional Sales Reps Produce Product Information Literature and organise promotions

    • Graphic Design
    • 1 - 100 Employee
    • Project Manager
      • Dec 2004 - Apr 2006

      Witham, Essex I was promoted to Project Manager, responsible for working within the studio to liaise between the studio and the team at Tesco HQ, to organise the day to day running of packaging projects to ensure all information is captured and actioned to meet customer needs, client satisfaction and difficult deadlines. • To liaise with printers, suppliers and designers to resolve any problems as quickly and as accurately as possible to ensure deadlines are not jeopardised. • To liaise with the… Show more I was promoted to Project Manager, responsible for working within the studio to liaise between the studio and the team at Tesco HQ, to organise the day to day running of packaging projects to ensure all information is captured and actioned to meet customer needs, client satisfaction and difficult deadlines. • To liaise with printers, suppliers and designers to resolve any problems as quickly and as accurately as possible to ensure deadlines are not jeopardised. • To liaise with the team at Tesco HQ and effectively communicate any issues to come up with a solution that will have the best outcome. • To provide cover on project workloads when another Project Manager was absent. • I was responsible for the Meat, Fish and Poultry categories and in June 2005 I took on the additional responsibility of managing the Frozen food category.

    • Project Administrator
      • Mar 2004 - Dec 2004

      As the Project Administrator my role was to assist the team Project Managers in the day to day lifecycle of food packaging artwork for one of the largest supermarket chains in the UK, ranging from the value to quality food brands : - To efficiently manage the distribution of artwork to the client ensuring all information is documented correctly and is legible. - To send pdfs of the artwork electronically to printers, suppliers, designers and the client for their comments and… Show more As the Project Administrator my role was to assist the team Project Managers in the day to day lifecycle of food packaging artwork for one of the largest supermarket chains in the UK, ranging from the value to quality food brands : - To efficiently manage the distribution of artwork to the client ensuring all information is documented correctly and is legible. - To send pdfs of the artwork electronically to printers, suppliers, designers and the client for their comments and approval. - To organise and ensure all post was ready to be dispatched in time for the daily couriers and all information was accurately documented in a spreadsheet to be emailed to all the project managers. - To manage additional workloads that the team often encountered during busy periods of the year.

Education

  • ICS Learn
    CIPD Level 5 Diploma in Human Resource Management, Human Resource Management
    2016 - 2016
  • Thurstable Comprehensive
    A Levels, English Language and Literature, General; Theatre Studies; Art and Design
    2001 - 2003
  • Thurstable Secondary SChool
    1997 - 2003

Community

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