PlusOne

QA/RA Officer & Scientific Writter

Company

Our client is a digital Health company providing worldwide access to a comprehensive Clinical Decision Support System (CDSS) for musculoskeletal pathologies. Their ambition is to improve patient treatment by providing caregivers, surgeons patients and medical devices companies with a state of the art CDSS. Their mission is to identify the optimum treatment and surgical therapeutic plan for each patient and assist medical devices companies to conduct virtual clinical studies for the testing of implants and prosthetic ankles.

If you are sharing their vision of developing life-improving services and if you are looking for digital health development challenges amongst a dynamic and innovative team, consider collaboration with this fast-growing company.

Role

  • Maintain ISO certifications.
  • Products recording according to the deadlines.
  • Treatment of non-conformities.
  • Scientific writing on QA/RA & Clinical aspects.

Duties and responsibilities

  • Contribute to the integration of the company’s quality policy.
    Ensure that this policy is understood, implemented and maintained at all levels in the organization.
  • Generate a spirit of quality among all of the company's staff member.
  • Report the operation and effectiveness of the quality management system to the management.
  • Ensure the quality system implementation, participate in internal and external quality audits in collaboration with the team of experts.
  • Participate in registrations with Notified Bodies and Competent Authorities in collaboration with the QA Manager.
  • Contribute to the definition, implementation and evaluation of the company's regulatory strategy to ensure products conformity according to the local regulations.
  • Identify applicable standards and regulations and ensure regulatory watch.
  • Manage software releases developed by the company
  • Manage all deviations and customer complaints.
  • Participate actively in the development and maintenance of the Document Management System
  • Write scientific documents, regulations, procedures and documents related to clinical activities.

Profile

  • Scientific Engineering background (Master degree required).
  • Minimum 2 years of experience in a similar position
  • Excellent organizational skills, flexibility and good interpersonal skills.
  • Fluent in French & English (Excellent writing skills in English).

If you wish to apply, please send your cv to our recruitment partner Plus One, Aurélie Cuisset, acuisset@plusonesearch.be

Please note that only selected candidates will be contacted.

Publication date

10.01.2019

Contact person

Cuisset

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