PlusOne

QA & RA Manager - Medtech - Namur

About PlusOne

The company s looking for a QA/RA manager to support the European and US market entry of the new generation of products. You will closely collaborate with our R&D, production and clinical teams and participate to the growth of the company from an operational point of view by ensuring compliance and effectiveness of our quality management system.

Company

Our client is MedTech company located in the area of Namur. This company is specialized in the development of diagnostic and therapeutic devices that detect and threat sleep apnea. The technology offers a revolutionary new way to measure brain commands at night, with unprecedented clinical results. This non-intrusive innovation allows patients to evolve with a less constrained medical solution.

After a successful launch in selected countries and after having validated company’s demand and positioning in the care pathway, the company is now growing strongly.

To reinforce their team, they are looking for a QA&RA Manager.

Role

The QA/RA manager is responsible for managing quality system development and maintenance and coordinating regulatory activities for the company.

Your Responsibilities:

  • Maintain and continuously improve the quality management system in order to meet compliance and business needs;
  • Continuously monitor quality & safety KPI’s and drive process improvement projects;
  • Ensure regulatory compliance;
  • Manage technical documentation;
  • Lead and support supplier selection, qualification and evaluation;
  • Lead and support customer complaints, CAPA, change control and FSCA processes;
  • Support client and regulatory audits and inspections;
  • Manage the QA department, set goals and objectives;
  • Participate in the management committee of the company

Profile

    • Master’s degree in a scientific/engineering area required;
    • Strong interest in new technologies (wearables, digital medicine, artificial intelligence);
    • A first and relevant experience in medical device quality assurance (2-3years);
    • Working knowledge of ISO 13485, European medical device regulation, FDA;
    • Audit expertise;
    • English and French languages;
    • Strong communication skills, written and oral;
    • Ability to be flexible and adaptable in the face of changing priorities;
    • Proven ability to work independently or in a cross-functional team setting;
    • Strong team player, encouraging cross-functional functioning;
    • Strong conviction and collaborative influencing skills;

Highest standards of ethics in all circumstances

  • Maturity and impact in dealing with stakeholders and key external bodies;
  • Demonstrable experience of working to high quality standards and resolving issues;
  • Very good organizational skills;
  • Ability to manage time and work independently.

Offer

Our client offers a friendly, dynamic and entrepreneurial start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.

Our client offers a full-time open-ended contract and interesting salary package and flexible advantages.

Publication date

05.09.2021

Contact person

Gaëlle Minet

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