PMS Quality Engineer M/F/X
Company Description Now a member of the Precision IO group, at Quantum Surgical, we are a company specializing in medical robotics and artificial intelligence. Our percutaneous ablation robotic platform, Epione®, is dedicated to the curative and early treatment of cancers. We thus offer a new approach to cancer treatment by standardizing access to care. More patients can thus benefit from innovative, better-targeted, and less invasive treatments. More than 1,400 patients have already been treated worldwide. Co-founded in 2017 and supported by a team of more than 140 employees, our company is headquartered in Miami, Florida, and has offices in Montpellier, France. We recently acquired NeuWave Medical. Together, our two companies now operate within the group: Precision IO, with the ambition of transforming standards of care in tumor ablation and interventional oncology through innovation.
Job Description We are strengthening our QARA team on Post Market Surveillance activities and are looking for a PMS Quality Engineer to manage complaint processing activities and support the Quality and Regulatory team to ensure safe and effective products. Depending on the company's needs, you may be required to support other activities related to Quality. This position is based in Montpellier. Your missions will be as follows:
Process daily customer complaints, including collection, analysis, investigation, and reporting of complaints.
Ensure communication with the Customer Support team for complaint detection, data collection, report establishment, as well as the launch and follow-up of corrective actions.
Ensure Europe (MIR) and US (MDR) medical device vigilance within the prescribed deadlines, and escalate the complaint if necessary.
Communicate with competent authorities.
Participate in the health risk assessment process in collaboration with the risk management team.
Review Device History Records (DHR) associated with product manufacturing.
Coordinate and participate in investigations with stakeholders and technical teams/subject matter experts.
Follow up and reconcile Field Safety Corrective Actions (FSCA, FSN, recall...).
Establish and ensure proactive review of post-market surveillance data and undertake actions if necessary.
Participate in the application of Risk Management processes to existing and new products.
Ensure adequate documentation of post-market surveillance activities (complaint file, HHE, PSUR, ...).
Provide PMS input data to the Engineering department for the development of new products as well as for the improvement of current products.
Provide regular reports to the PMS Manager.
Required Profile Required You hold an Engineering degree or equivalent.
You have at least 2 years of experience in post-market surveillance within a medical device company.
You have experience and knowledge of the regulated environment under MDR (EU) and 21 CFR (FDA), including good knowledge of vigilance and complaint management requirements.
You are familiar with risk management (ISO 14971).
You are rigorous and organized and have good synthesis and analysis skills.
You know how to communicate effectively and establish relationships with internal and external stakeholders.
You have excellent organizational and communication skills.
You have a strong team spirit.
You have a good level of English (oral and written).
Desirable You have experience with a medical robotics device (software and mechanical).
Working at Quantum Surgical (Precision IO Group) means: Joining a talented and creative multicultural team, and participating in the technological and human adventure of a rapidly growing company.
Sharing our values of innovation, teamwork, and a results-oriented culture.
Taking on stimulating technical challenges.
Benefiting from competitive compensation and benefits (Fixed salary + variable, Swile meal vouchers, WellPass).
A remote work policy of one day per week.
The recruitment process: Pre-selection interview (Teams video) - HR – 30/45 minutes
Technical interview (Teams video) – PMS Manager & HR – 30/45 minutes
Interview at our premises – QARA Director, PMS Manager & HR - 1h/1h30
Diversity is an integral part of our values. Therefore, we study all applications with interest without distinction that may be linked to a physical or moral characteristic. The compensation range mentioned in this advertisement includes both the fixed and variable parts. Website: https://quantumsurgical.com/ Company video: https://www.youtube.com/watch?v=mZmC3-KcrtM