Job type: Full-time
Gross salary: From 40k€ to 45k€ (bonus included) – depending on professional experience
Hemerion Therapeutics is a health tech company at a clinical level. Hemerion results of over 10 years of leading academic and clinical research on innovative approaches to treat Glioblastoma. These new technologies have been evaluated to treat brain cancer through a first-in-human clinical trial. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.
Hemerion Therapeutics is looking for its future Quality Assurance (QA) Engineer who will participate in the establishment and monitoring of the Quality Management System of the company. The QA Engineer will coordinate and perform quality assurance and will ensure product development activities are done according to applicable Quality System Regulation (QSR).
On-site job, at Hemerion Therapeutics’ offices: 37 rue Denis Papin, 59650 Villeneuve d’ascq, France.
Within the supervision of the CTO and the Quality Affairs Manager, the QA Engineer will:
- Implement QMS activities according to the requirements of 21 CFR 820, ISO 13485:2016, the ICH Q10 and other applicable regulation to product realization.
- Manage document control activities according to the FDA and international regulations. This includes ensuring that all document changes are processed and approved according to the standard operating procedures.
- Support the company in achieving its ISO 13485:2016 certification.
- Manage quality records including device history records, QA records, test reports, manufacturing records, and equipment records.
- Work with Product Development to ensure that design control process is followed according to applicable regulation.
- Perform incoming inspections, final product release inspections, and preliminary product failure investigation/testing as a part of CAPA process.
- Maintain and monitor product traceability data from receiving through the final destination.
- Participate in supplier management activities.
- Participate in equipment and process validation program including IQ, OQ, and PQ processes according to 21 CFR 820.
- Participate in process FMEA and control plans associated.
- Manage calibration programs and track equipment maintenance to ensure that measuring and critical operational equipment is timely calibrated and validated.
Master’s degree in quality engineering.
- Minimum 2 years of experience in medical device industry.
- Experience in manufacturing of sterile medical device is preferred.
- Broad understanding of 21 CFR 820, ISO 13485:2016, and European Regulation on medical devices.
- Experience scheduling, managing, and developing SOPs and Work Instructions.
- Experience in medical device manufacturing requirements for product or process change management is preferred.
- Excellent verbal and written communication in French and in English.
- Organized and able to meet deadlines.
- Strong planning, technical, and problem-solving skills
- Ability to prioritize and multi-task with little supervision
- Dynamic environment with opportunities for advancement within the company
- International and growing company