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Summary

experienced professional in the field of Regulatory Affairs & Quality Assurance & approbation of Medical Devices class iia and ISO 9001:2008.

Experiences

Current Experience

  • Owner / Manager QA/RA & Certified Lead Auditor ISO 13485


    Since December 2014
    • be the qms management representative • chair the management review meetings • maintain the Quality Management System to FDA regulations, ISO 9001, and iso 13485 • assure that the corrective and preventative action program is effective • provide quality Planning for products, verifications and validations • develop metrics to measure quality of products and efficiency of the qms • assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary • manage an internal Auditing program • provide qa system Training • manage the gage control and calibration programs • monitor/audit design control process • assure proper maintenance of quality records • monitor the regulatory environment for changing quality policies, processes and procedures • manage receiving inspection • assure an effective incoming inspection process • set annual quality goals • review product release processes • oversee the document control system certification of Medical Devices • ce certifcation of Medical Devices • Be the QMS management Representative • Chair the Management Review meetings • Maintain the Quality Management System to FDA regulations, ISO 9001, and ISO 13485 • Assure that the corrective and preventative action program is effective • Provide Quality Planning for products, verifications and validations • Develop metrics to measure quality of products and efficiency of the QMS • Assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary • Manage an internal auditing program • Provide QA system training • Manage the gage control and calibration programs • Monitor/Audit Design Control Process • Assure proper maintenance of Quality Records • Monitor the regulatory environment for changing Quality policies, processes and procedures • Manage Receiving Inspection • Assure an effective incoming inspection process • Set annual quality goals • Review product release processes • Oversee the Document Control System Certification of medical devices • CE Certifcation of Medical devices

  • Quality Assurance Manager a.i.


    Since January 2014
    • qms management representative • chair the management review meetings • maintain the Quality Management System to FDA regulations, ISO 9001, and iso 13485 • assure that the corrective and preventative action program is effective • provide quality Planning for products, verifications and validations • develop metrics to measure quality of products and efficiency of the qms • assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary • manage an internal Auditing program • provide qa system Training • manage the gage control and calibration programs • monitor/audit design control process • assure proper maintenance of quality records • monitor the regulatory environment for changing quality policies, processes and procedures • manage receiving inspection • assure an effective incoming inspection process • set annual quality goals • review product release processes • oversee the document control system • QMS management Representative • Chair the Management Review meetings • Maintain the Quality Management System to FDA regulations, ISO 9001, and ISO 13485 • Assure that the corrective and preventative action program is effective • Provide Quality Planning for products, verifications and validations • Develop metrics to measure quality of products and efficiency of the QMS • Assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary • Manage an internal auditing program • Provide QA system training • Manage the gage control and calibration programs • Monitor/Audit Design Control Process • Assure proper maintenance of Quality Records • Monitor the regulatory environment for changing Quality policies, processes and procedures • Manage Receiving Inspection • Assure an effective incoming inspection process • Set annual quality goals • Review product release processes • Oversee the Document Control System

Past Experience

  • Business Controller / Manager QA

    January 2014 --- December 2014
    responsible for all day by day financial operational processes, Planning & control cyclus, and improving the working capital position for all entities. • financial administration & financial control - monthly reporting. - Planning & control cycle (both as Financial Controller and as quality manager). - Budgeting. - billing/invoicing - cash management (accounts receivables/payables and cash application) • Human Resources management - contracts. - insurance & pension. • ISO qulaity manager

  • Manager Finance / Controller

    October 2012 --- December 2013
    responsible for all day by day financial operational processes, Planning & control cyclus, and improving the working capital position for all entities. • financial administration & financial control - monthly reporting. - Planning & control cycle (both as Financial Controller and as quality manager). - Budgeting. - billing/invoicing - cash management (accounts receivables/payables and cash application) • General Management - Human Resources management - contracts. - car park. - insurance & pension. • ISO qulaity manager

  • Assistent Controller a.i.

    June 2011 --- July 2012
    jul-11 untill feb-12 - geesink norba bv, assistant Controller mar-12 - alfa groep bv, Controller

  • Controller a.i.

    August 2009 --- May 2011
    i was responsible for the administration of mee ugv, the monthly reporting, Budgets, and annual reporting. beside it i was involved in several projects as cost price calculation etc.

  • Financial Controller

    December 2008 --- August 2009
    on behalf of choco support i write my thesis about costprice calculation based on activity base costing.

  • Financieel specialist

    November 2006 --- December 2008
    from november 2006 until june 2008 i was assigned as Coordinator financial project a.i. at nissan europe SAS . nissan provides unique and inovative automotive products and services that deliver superior measurable values to all stakeholders in alliance with renault. my mainly responsibility was coordinating the implementing of the new full integrated invoicing system and thereby all (financial) processes. before the laungh of this systym and new organization structure, all local sites were independent and should be converted to regional business units (rbu’s). in accordance with the changes in the organizational structure the financial processes and procedures should also be adapted concerning this new organizational structure. several countries where combined into one rbu. this caused processing issues and legal & tax issues which has to be resolved. it was my task to coordinate these resolving actions. i was mainly working for rbu west, but also for the other rbu's. beside it i was responsible for the project team existing of 8 members who execute the operational supporting job for all the rbu’s. also i was Member of the european financial project team. my second task was providing all kind of management information likes the monthly inventory reporting, error lists, comparing reports between systems, etc. part of my assignment was improving and secure all financial processes, and improving and secure the new full integrated invoicing system. my second assignment was by ricoh. i was my responsibility to merge two gl’s into 1 gl. also i provide the monthly reporting. i worked by ricoh from june 2008 until december 2008.

  • Financieel Interim Professional

    September 2005 --- November 2006
    my first assignment was alfa laval benelux bv. my mainly task was reconcile the intercompany position and create the payments batches. my second assignment was by gelderblom cnc machines bv. it was my mainly task to split the administration into two entities and convert the administrations from exact for Windows to exact globe.

  • Assistent Controller

    December 2003 --- September 2005
    my first assignment was redesigning the management information system. after completeness of this management information system i was responsible for all reporting issues like the monthly reporting, Budgets, and annual reporting.

  • 1e Medewerker Finance & Control

    March 2003 --- December 2003
    my first assignment was redesigning the model for the Budgets. after completeness of this management information system i was responsible for all reporting issues like the monthly reporting, Budgets, and part of the annual reporting.

  • Medewerker Financiële Administratie

    April 2002 --- March 2003
    it was my mainly task to process all purchase invoice's and bank transactions into the financial system.

  • Junior Financieel Interim Professional

    June 2000 --- April 2002
    my first assignment was by planet Internet. my mainly task was informing their customers about their outstanding invoices.

  • Vakantiewerk

    January 1996 --- January 1997
    i did several jobs for pilz.

Personality

Self Assessment :
Analytical thinking

Knowledge

Self Assessment :
Quality Assurance (QA)

Skills and Expertise

Self Assessment :
Labeling compliance with local regulations

Education

  • Lead Auditor ISO 13485 in from BSI Group in 2014
  • Bachelor of Science (BS) in Bedrijfseconomie from Hogeschool van Amsterdam in 2009
  • student in ASCO I from NIVE in 2006
  • VBO in VBO - Motorvoertuigentechniek from Glasstad Scholen Gemeenschap in 1996
  • VBO in VBO from Oosterlicht College in 1994
  • Basisschool in Basis school from Basisschool in 1992

Area / Region

Ameide, Nederland

Others

Driving License
  • Yes

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