Document Control Specialist medior/senior

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  • Aanbod Max. € 70,000
  • Functiegroep Engineering
  • Dienstverband Fulltime
  • Vacaturenummer 9098600
  • Locatie Eindhoven
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

We are looking for an enthusiastic contingent worker in the area of change, document and record control with experience in business/quality management systems (ISO 9001 / ISO 13485) and FDA (21CFR) regulations in an international environment.

Functie

You will be a member of the support group of the Philips Document & Record management system. In your role you will:

  • Support lower level Document Control Specialists
  • Controls & maintains the document management system for issuance recording/filing, tracking, retrieval of documents like procedures, plans, QA/QC records, Specifications and related documents
  • Leads and supports (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel

Key areas of responsibilities

  • Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope
  • Establish Document Control support to authors and (local) process owners in defining and producing lean quality system documents and records
  • Ensure proper quality of the content of documentation and records
  • Establish and manage proper document review processes
  • Ensures availability/publishing of controlled documents
  • Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Aanbod

You will be employed by YER and seconded to Philips. You shall be working with a team of international colleagues in which you can be sure of a healthy work-life balance. We will also reward your effort and achievements with an attractive salary and fringe benefits.

Profiel

Must have items:

  • 3 to 5 years related experience in change control and/or document control field
  • Familiarity with document management system tools
  • Experience running effective process improvement projects
  • Knowledge of FDA regulations and regulatory requirements
  • Preferred qualifications:
    o Engineering background
    o Prior group or team leadership experience
    o Procedural or technical writing experience
    o Understanding of modelling tools
    o Awareness of Project Management Institute standards

Required competences:

  • Knowledge about quality management, regulatory management
  • Being a Q&R Business Partner
  • Able to support Computer Systems Validation
  • Able to work in a virtual environment
  • Advanced MS Office user (inclusive SharePoint Designer)

Nice to have items

  • Procedural or technical writing experience.
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