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Staff RAQA Specialist

Locatie

Venlo

Publish date

01-10-2020

Naam organisatie

Suc6! Recruitment B.V.

Function content

For a fast-growing international company, we are looking for an experienced Staff RA/QA Specialist (location Venlo). This company is known for its innovative products and solutions in the healthcare industry and is one of the world's leading companies in medical devices.

Staff RAQA Specialist (Medical Devices, 60K, Fulltime)

The Staff RAQA Specialist is owner of multiple QMS processes and acts independently as a liaison for the CDC in regarding Quality Management System, Value Added Services and Continuous Improvements. The Staff RAQA Specialist defines and develops requirements to make sure the CDC organization keeps meeting the Legal, Corporate, ISO 13485 and FDA RAQA requirements. This role ensures a standardized and structured approach to the organisation, CDC and RAQA processes which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.



The ‘Staff RAQA Specialist’ is responsible for:

  • MS Process Ownership, KPI management and including where applicable Document and Record Control.
  • CAPA process handling, tracking progress and status
  • Input owner to support the Organization regarding Quality Policy, QMS, Regulatory and Quality in general
  • Independently working in teams regarding Process and Organization Change Management
  • Act where needed as RAQA manager back-up towards the local teams and as a delegate in daily processes and projects
  • Any other RAQA activities as defined by the RAQA Manager
  • Supporting and developing the ELPO VAS strategy on labeling and Kitting
  • QMS processes reporting to stakeholders in and outside CDC.
  • Supporting M&A, projects and Business integrations to enable growth.
  • Preparing and Acquiring correct Management and RAQA approvals where needed
  • Network and work with global stakeholders to review Strategy and CDC QMS and processes

Function requirements

  • Vocational Education (HBO+).
  • A minimum of 5 years’ experience in RAQA role
  • Education in or knowledge of logistics processes, RAQA processes and MDR-regulations
  • Proven experience of working in the Medical Devices industry specifically regarding value added services activities
  • A minimum of 5 years working in an ISO13485, FDA medical devices or Quality function related environment.
  • Customer and Service minded, Hands-on, Proactive.
  • Excellent communication and interpersonal skills resulting in Business improvement and increased results
  • Team player and able to positively influence others

What you get in return

  • A direct contract with our client
  • Great salary based on your experience (€ 60K)
  • 10% bonus opportunity based on your performance and the company performance
  • 8.5% holiday allowance
  • 27 vacation days
  • Travel allowance
  • 40% discount on your gym membership and bicycle

A Great Place To Work

And yes that's 100% true! Fortune named this company A Great Place To Work for the seventh year in a row, ranking it in the top 10! This company is known for its innovative products and solutions in the healthcare industry. Founded in 1941 this company has expanded to over 30 countries worldwide and is still growing. Your workplace will be located in the European Distribution Center (EDC) in Venlo.

Want to know more? Then contact Rene van den Borst on 06 - 1881 7501.

Despite of corona crisis, applying for a job at Suc6! Recruitment is possible. Together we can easily get in touch online using Skype, Zoom or Whatsapp.

Apply

Interested? Then click on the application button or send your resume to r.vdborst@suc6recruitment.nl

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