Founded in 2010, CryoTherapeutics is an early stage European innovator based in Awans. They develop a catheter for use by interventional cardiologists to treat atherosclerotic plaque that causes heart attack by delivering cryoenergy to the coronary arteries.
Cryo Therapeutics aims to develop and market the novel cryoenergy therapy initially for patients that have suffered a heart attack, and in the longer term also for patients identified by diagnostic methods as being at future risk of heart attack. For additional information about the company, please visit http://www.cryotherapeutics.com/
Late 2021, The Company closed about 12.3M€ which ensures great business ambitions thanks to strong international investors.
In order to support the expansion of the team in Awans (Liège), we are looking for a (m/f) : Quality Engineer.
Reporting to the QA Manager and working closely with the R&D team, the Quality Engineer contribute to the implementation and maintenance of the Quality Management System in accordance to applicable Regulatory Standards and internal processes of the company.
Your main responsibilities are:
- Write, revise and maintain procedures, forms and ensure appropriate records retention.
- Collaborate with R&D colleagues in order to ensure the maintenance of the design history file.
- Verify the batch manufacturing and release documentation and product traceability.
- Establish timelines and ensures adherence to timely execution of the quality plan.
- Coordinate actions plans in relation to the quality plan, non-conformities, change controls, management reviews, and normative watch.
- Perform internal/external audits and process reviews in accordance to the quality plan.
- Support the product registration processes for quality-related matters.
- Report work evolution on a regular basis.
- Engineering Master’s degree in a relevant scientific discipline.
- 3 to 5 years’ experience in a Quality environment (ideally in automotive, aeronautics, or in any similar sector).
- In-depth knowledge of the organization of QMS, preferably ISO 13485:2016 standard and/or US FDA Quality System Regulations.
- Experienced in medical device requirements and design control processes is an asset.
- Qualification as internal auditor is an asset.
- High level of attention to detail, analytical and excellent organizational skills.
- Fluent in English, written and spoken. Knowledge of another language is an asset.
- A challenging position with a high potential innovative medical device company.
- The possibility to take part in key-projects directly linked to the device development.
- To work in a human-sized, collaborative and respectful environment.
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with your responsibilities and experience.
Your application and related information will remain strictly confidential.