PlusOne

QA Project Leader

Company

Our Client is a is an innovative Medical Devices company based in Liège. The company has been developing for more than 30 years a range of innovative products, designed in partnership with ophthalmic surgeons and in close cooperation with specialized research centres and universities.

Their expertise covers all steps of development and manufacture of intraocular lenses extending from polymer chemistry to sterilization processes, responding to the strictest requirements in quality.

Role

  • Owner of the change control process. Organization of the change control boards. Ensures coordination of the changes of all departments.
  • Design changes process improvements in the existing process.
  • Batches release, rework release, packaging release.
  • Participates to multiple actions from MDR (MDD), FDA, ISO 13485, ISO 9001 and MDSAP requirements in order to update our QMS.
  • Participates or leads defined QA projects.
  • Organizes QA topics trainings to other departments (preparation, presentation, support to shopfloor/customer managements).
  • Work in our documentation control QA process, as implemented in our eQMS and act as support for the development of the records control.
  • Implements the new eQMS implementation in line with the group integration (2022).
  • Ensures that the design control process is in accordance with the requirements (process, documentation, localization of the records, respect of timings).
  • Helps integrate the new batches release process (Memphys project 2021-2022).
  • Internal and external auditor (suppliers, distributors).
  • Deals with the QA parts in contracts suppliers/distributors.
  • Performs processes risk analysis.
  • Actively participates to audits from Notified Body/Competent Authorities.

Profile

  • You have a Bachelor or a Master's degree with a scientific orientation or an equivalent
  • Experience in the ISO 13485 field is needed (5 to 10 years of active day to day work in this context). Knowledge of MDR/MDD, MDSAP and ISO13485/ISO9001 requirements.
  • Knowledge and experience of FDA regulation in Medical Devices.
  • Fluent in English.
  • Flexible mind in order to integrate new projects/new priorities easily.
  • Scientific education.
Team spirit.

Offer

  • You are joining a dynamic, fast-growing environment at the cutting edge of technology and innovation in a company with great human values, which encourages its teams to take initiatives and contribute ideas that contribute to its success.

Publication date

02.06.2021

Contact person

DORTU

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