Symetis SA, a Boston Scientific Company, develops and produces innovative, minimally invasive heart valve replacement devices. The company's product ACURATE neo? and delivery systems, based on proprietary design and delivery technologies, are marketed and sold in key markets in Europe and in other markets, and are well positioned to target the constantly growing TAVI market.
Purpose and Passion:
At Boston, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life's work.
Tasks and Responsibilities:
Demonstrate commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system
Understand and comply with all the regulations governing the quality systems.
Ensure their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work
Improve existing quality processes
Facilitate new products implementation and make sure quality standards are aligned with company requirements
Translate design controls into quality processes
Understand external clients (patients, health authorities, doctors...) expectations/requirements
Several years of experience in a quality role in the medical device industry
Experience with MDD/EU MDR and PMA registration in USA (exposure to FDA) is mandatory
Degree in mechanical or biomechanics or biosciences
Able to understand a final product in terms of compliance and documentation
Knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
Ability to work in cross functional teams
Fluent in both French and English