Offre d'emploi : Quality Engineer
Founded in 2009, CryoTherapeutics is an early stage European innovative company that has established its operations in Awans (Liège). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries. For additional information about the company, please visit http://www.cryotherapeutics.com/
CryoTherapeutics aims to develop and market the novel cryoenergy therapy initially for patients who have suffered a heart attack, and in the longer term also for patients identified as being at future risk of heart attack. CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue development of this technology with the aim of starting clinical studies later this year.
In order to support the expansion of the team in Awans, we are looking for a (m/f):
Reporting to and working closely with the Head of Regulatory Affairs, you 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.
- Engineer or Bachelor’s or Master’s degree in a relevant scientific discipline or equivalent through experience.
- Around 3 years of experience in the Medical Device (preferred) or Pharma industry.
- In-depth knowledge of the organization of QMS, ISO 13485:2016 standard (preferred) and/or US FDA Quality System Regulations.
- Experienced in medical device requirements, QMS and design control processes is an asset.
- Excellent interpersonal, communication and presentation skills.
- High level of attention to detail, excellent organizational skills and time management, flexibility.
- Fluent in English, written and spoken. Knowledge of another language is an asset.
- Willing to travel abroad occasionally.
- A challenging position within a high potential innovative medical device company.
- The opportunity to join a company that develops a disruptive technology to improve patients’ lives.
- To work in a human-sized, collaborative and respectful environment
- An attractive compensation package in line with the position’s responsibilities and your experience.
Please send your CV together with an adapted cover letter via http://www.pahrtners.be/job/quality-engineer/ or to email@example.com
Your application and related information will remain strictly confidential. Cryotherapeutics is an equal opportunity employer.
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