Head of Quality / RA

EMS is a global leader in the design, manufacturing, and sale of devices used for medical and dental treatments. With over 40 years of expertise, EMS embodies Swiss precision and craftsmanship, delivering innovative solutions in:Dental Prevention: Inventors of Guided Biofilm Therapy (GBT), a proven protocol for biofilm management, and creators of Airflow, Perioflow, and PIEZON technologies.Urology: Pioneering endoscopic lithotripsy solutions with the LithoClast and LaserClast product range.Shock Wave Therapy: Innovators of RSWT (Radial ESWT) and the Swiss DolorClast Method for treating musculoskeletal and dermatological conditions.At EMS, we are driven by our core values: Respect, Excellence, and Client Orientation. Our mission is simple: to ensure happy and healthy patients, successful clinicians, and passionate partners through the least invasive and clinically proven treatments.MISSIONAs the Head of Quality / RA, you will report directly to the Chief Operating Officer (COO), leading EMS’s Quality Department and regulatory compliance efforts to uphold and improve our globally recognized quality standards.TASKS & RESPONSIBILITIESTeam Management:Organize and oversee the Quality Department’s operations.Train and supervise employees to adhere to EMS’s quality management system.Motivate and encourage initiative for process improvements.Regulatory Compliance:Serve as EMS’s Person Responsible for Regulatory Compliance (PRRC), ensuring:Product conformity checks before release.Up-to-date technical documentation and EU declarations of conformity.Post-market surveillance obligations.Reporting compliance with Articles 87 to 91 of the MDR.Issuance of investigational device statements per Annex XV of the MDR.Quality Management:Establish, implement, and continuously improve EMS’s quality policy and system in line with ISO 13485 and FDA QSR standards.Authorize product releases and registrations.Oversee third-party, internal, and supplier audits.Analyze quality costs and implement actions to enhance product quality.Manage non-conformities, complaints, and corrective/preventive actions.Cross-Functional Collaboration:Ensure seamless communication and cooperation with all departments.Provide quality-related advice and training across the organization.Organize and present data for Quality Management Reviews.Documentation & Compliance:Supervise documentation group activities, ensuring accuracy and relevance of technical documentation.Manage product labeling and ensure links between documentation and products (e.g., Device Master Files).Product Compliance Laboratory:Oversee the activities of the Product Compliance Laboratory to ensure quality and compliance with standards.Strategic Contributions:Develop and align the Quality strategy with EMS’s business units.Implement risk management and supplier process validations.Define and supervise the regulatory strategy to meet business needs efficiently.EDUCATION & PERSONAL SKILLSMaster’s degree or equivalent in Quality Management, Engineering, or related field.Extensive experience in Quality Management within the medical device industry or related sectors.Proficiency in French and English; German is a plus.In-depth knowledge of ISO 13485, MDR, and FDA QSR standards.Expertise in quality audits, regulatory compliance, and risk management.Strong leadership and team management abilities.Excellent analytical and organizational skills.BEHAVIORAL COMPETENCIESAt EMS, we have defined key competencies that support our Vision and Mission statements. These competencies form the cornerstone of EMS performance drivers:Teamwork and Collaboration: Builds and maintains positive working relationships while demonstrating respect, empathy, and understanding. Contributes to a harmonious and productive team environment.Adhering to Principles, Acting with Values and Integrity: Demonstrates honesty and integrity, adhering to ethical principles and EMS’s core values. Ensures compliance by diligently following policies, rules, and regulations.Excellence in Execution: Consistently plans, organizes, and delivers high-quality results. Exceeds expectations through strong execution and timely task completion.Agile Thinking: Demonstrates flexibility and adaptability to change while proactively solving challenges. Adjusts quickly to new conditions with resilience and creativity.Innovation and Creativity: Encourages imaginative thinking and generates new approaches and solutions. Actively seeks opportunities to improve processes, products, and services.WHY JOIN US?At EMS, we offer an exciting opportunity to be part of a global and successful company, where you can thrive in a pleasant and supportive work environment. Enjoy the benefits of a future-proof, permanent position with a flexible and self-responsible working culture, all within the framework of our unique “I Feel Good” corporate culture.We take pride in fostering diversity and inclusivity in the workplace, encouraging individuals from all backgrounds to join our team and contribute to our mission. #J-18808-Ljbffr