About us
FKG Dentaire Sàrl – a Henry Schein company - is at the forefront in the development, manufacturing and distribution of high precision dental products for dentists, endodontists and laboratories. Our mission is to strive to innovate new ways of working: more respectful, more efficient, more agile, more ergonomic, and safer - serving new generations, promoting new visions of life, for us, for you, and for your patients. For nearly a century, we have been constantly reinventing what we thought we knew. We are committed to developing a culture of performance by promoting equity, loyalty and respect.
We embrace change, the kind that empowers endo to Change the game.
Our mission is to make endodontics safe and easy through innovative, high-quality and less invasive solutions
To complete our Quality Team, we are looking for a
Quality Engineer
Role mission
Participate in the development and deployment of our quality management system and report on its effectiveness and any need for improvement, both for manufacturing and suppliers.
Your responsibilities
· Contribute to the smooth running of the quality department and the maintenance of certifications for the company and its products
· Actively contribute to the continuous improvement of our quality management system and our organization
· Ensure effective communication with your external contacts, customers, or suppliers, as well as other departments within the company, and support them in all matters related to quality assurance
· Raise awareness among your contacts of the applicable regulatory requirements and quality management system requirements and actively contribute to training company employees on these aspects
· Lead quality projects such as the integration of new requirements into our QMS, validation of manufacturing processes, or CAPA processing
· Participate in all activities of the quality department: conducting internal and supplier audits, handling customer complaints, managing documents and their modifications, managing inspection specifications, analyzing data, managing risks, defining and monitoring performance indicators
· Coordinate the processing of internal and supplier non-conformities
· Collaborate with the technical and production departments on all quality-related issues such as problem solving, process improvement, and new production equipment development
Your profile
· Higher education in science or engineering
· Minimum 3 years of professional experience in the field of quality applied to medical devices
· Knowledge of the main standards and regulations applicable to our field (ISO 13485:2016, Regulation (EU) 2017/745, 21 CFR Part 820, and other regulations applicable in MDSAP jurisdictions)
· Knowledge of statistical techniques related to process control, inspections, and sampling plans
· Experience with an eQMS (electronic quality management system) would be a plus
· Good command of MS Office tools (Word, Excel, PowerPoint)
· Good level of spoken and written English (B2)
· Team spirit
· Excellent analytical skills
· Pragmatism, proactivity, rigor
· Excellent communication and interpersonal skills
We offer
· A stimulating and dynamic work environment at the cutting edge of industrial automation
· Opportunities for professional development and career advancement
· A collaborative and inclusive corporate culture that values innovation and teamwork
· Attractive benefits (free parking place, home office, flexible work hours, minimum 5 weeks’ vacation, health insurance participation)
Entry into function : immediately or to be agreed
If you recognize yourself in this job description, are dynamic and interested in taking on challenges in a growing company, then we look forward to receiving your full application.
We look forward to discovering your talent and discussing how you can contribute to our success !