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.
Due to an increased workload, my client is looking for a Metrology & Validation Engineer to complete their QC Team.
You will ensure that the metrological means match with the needs of the departments (R&D, Manufacturing, production, QC). You’ll also manage the validation of new production equipment, manufacturing processes and computerised systems linked to the production and quality control processes. Finally, you’ll write documents related to your work and ensure their implementation in the quality control and production department.
- Define, select and implement the test equipment used during product manufacturing :
- Define the calibration methods for new measuring equipment
- Ensure that the calibration of existing equipment is maintained
- Define the instructions
- New product, new equipment, new method and new software (linked to production and QC): participation in the design of validation procedures, in agreement with the R&D Manager, Industrialisation Manager and QA & Regulatory Affairs Manager
- Define and validate quality control procedures and ensure their transfer to Quality Control
- Approve contract laboratories carrying out specific analyses as part of the product and process verification and validation phases
- Write equipment validation protocols (IQ-OQ-PQ) and ensure that the appropriate validations are carried out
- Approve control specifications, sampling instructions, test and control methods for sourced raw materials and components
- Participate in the investigation of complaints related to product quality.
- Participate in project meetings organised by the R&D department to anticipate future needs in terms of metrology and industrial process validation
- Provide support in the development of verification and validation procedures for a new product
- Provide occasional support to the R&D department at various levels including the implementation of verification and validation tests.
Communication with the Quality System :
- Communicate any non-conformity to the responsible person(s) and the QA & Regulatory Affairs Manager
- Communicate to the responsible person(s) and to the QA & Regulatory Affairs Manager any unusual fact or problem that could affect the smooth running of the tasks to be performed.
- You have a Master’s degree in engineering or another technical field related to the position.
- You have between 2 and 5 years of experience in the same position
- You have very good knowledge in French and English (written, spoken and reading)
- You have a first experience with equipment validation and metrology in medical device
- You are rigorous and disciplined, comply with regulations and procedures
- You are autonomous and capable to organise your work independently
- You are proactive and not afraid to seek out information
- You are team spirit oriented
Our client’s offer
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium and has an international scope.
This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.