PlusOne

QA Associate - Medical Devices - Liège

Company

Our client is a medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stage, with various potential therapeutic applications.

Role

You are looking for a professional challenge that allows you to work in a fast-moving and clinical stage company in order to endorse responsibilities in Quality?

You want to use your expertise in Quality to contribute to operational activities in that field but also to strategic projects? Thanks to your experience in Medical Devices you are able to work autonomously and to participate to the development of this fast-growing company?

Plus One can offer you this great challenge:

Your key responsibilities:

  • You contribute to the Company Quality Objectives.
  • You maintain the Quality Management System by ensuring compliancy to international regulatory requirements for medical devices.
  • You support the implementation of quality improvement initiatives across the organization.
  • You provide management and/or guidance in process or product investigations.
  • You manage internal and external (supplier) audits.
  • You utilize process validation methodologies to ensure that equipment/ process changes are robustly transferred to production and/or service activities.
  • You review of procedures, change notices, field communications, and other supporting service documentation.
  • You perform and documents product inspections (goods receipt inspection, incoming inspection and final inspection).
  • You perform product releases.
  • You participate on special projects as assigned by Manager.

Profile

  • Bachelor’s or master’s degree in Sciences, or equivalent through experience.
  • First experience (2-5 years) in quality operations.
  • Qualified knowledge of Medical Device Regulations (ISO13485).
  • You are able to understand and interpret medical device regulations and standards and apply them in a practical and consistent manner.
  • You are autonomous and have a hands-on and pragmatic mind-set.
  • You are able to work and collaborate effectively with internal and external actors to achieve company objectives, including audits.
  • You have excellent communication and influencing skills.
  • You are fluent in English. A good command of French and other languages is an asset.

Offer

  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Publication date

03.01.2020

Contact person

Gaëlle Minet

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