About Us
FKG Dentaire Sàrl – a Henry Schein company - is a leader in the development, manufacturing, and distribution of high-precision dental products for dentists, endodontists, and laboratories. Our mission is to continuously innovate new ways of working that are more respectful, efficient, agile, ergonomic, and safer. We aim to serve new generations, promoting fresh visions for us, you, and your patients. For nearly a century, we have been reinventing our understanding of the dental industry. We are dedicated to fostering a culture of performance that emphasizes equity, loyalty, and respect.
We embrace change that empowers endodontics to transform the landscape. Our goal is to make endodontics safe and easy through innovative, high-quality, and less invasive solutions.
Quality Engineer
Role Mission
As part of our Quality Team, you will participate in the development and deployment of our quality management system and report on its effectiveness and areas for improvement, both for manufacturing and suppliers.
Your Responsibilities
- Contribute to the efficient operation of the quality department and maintain certifications for the company and its products.
- Actively engage in the continuous improvement of our quality management system and organization.
- Ensure effective communication with external contacts, customers, suppliers, and other departments within the company, supporting them in all matters related to quality assurance.
- Raise awareness of applicable regulatory and quality management system requirements, and contribute to training employees on these topics.
- Lead quality projects such as integrating new requirements into our QMS, validating manufacturing processes, or managing CAPA.
- Participate in various quality department activities: conducting internal and supplier audits, handling customer complaints, managing documents and their modifications, overseeing inspection specifications, analyzing data, managing risks, and defining and monitoring performance indicators.
- Coordinate the processing of internal and supplier non-conformities.
- Collaborate with technical and production departments on quality-related issues such as problem-solving, process improvement, and new production equipment development.
Your Profile
- Higher education in science or engineering.
- Minimum of 3 years of professional experience in the field of quality applied to medical devices.
- Knowledge of key standards and regulations relevant to our field (ISO 13485:2016, Regulation (EU) 2017/745, 21 CFR Part 820, and other regulations applicable in MDSAP jurisdictions).
- Understanding of statistical techniques related to process control, inspections, and sampling plans.
- Experience with an eQMS (electronic quality management system) is a plus.
- Proficiency in MS Office tools (Word, Excel, PowerPoint).
- Good command of spoken and written English (B2).
- Strong team spirit and excellent analytical skills.
- Pragmatic, proactive, and rigorous approach.
- Outstanding communication and interpersonal skills.
We Offer
- A stimulating and dynamic work environment at the forefront of industrial automation.
- Opportunities for professional development and career advancement.
- A collaborative and inclusive corporate culture that values innovation and teamwork.
- Attractive benefits including free parking, home office options, flexible work hours, a minimum of 5 weeks’ vacation, and health insurance participation.
Entry into Function
Immediate start or to be agreed upon.
If you identify with this job description, are dynamic, and are interested in embracing challenges in a growing company, then we invite you to apply online using the form below. Please note that only applications matching the job profile will be considered.