Quality Specialist

About the job

BIOPTRON AG, SWITZERLAND

Part of the Zepter Group from 1996, Bioptron AG is a Swiss company that develops and manufactures medically certified light therapy devices.

Since its incorporation in 1988, BIOPTRON® has become a global brand that stands for innovative medical healthcare products, unrivalled in prevention, treatment and recovery in various medical conditions. BIOPTRON AG continues to invest in sophisticated research and new product development necessary to achieve optimal clinical effectiveness of light therapy treatments.

We are looking for an experienced Quality Specialist (80% - 100%)
based in Neuchâtel

• Further development and implementation of quality management system (QMS) within BIOPTRON AG (ISO 13485, MDR, MDSAP)
• Deputy to the Quality Management Representative & PRRC
• Ensures that the QMS is thorough, accurate, and compliant to support inspections and audits
• Collaborate with other departments to support quality related processes and procedures
• Provide Quality Management support on the projects
• Support and assist the company during external audits and inspections, e.g. Notified Bodies or Competent Authorities
• Lead entire QMS processes for instance, and not limited to: Management Review, CAPA; RISK; Change Management
• Supervising quality of records form product realization
• Main responsibility for the installation and updating of compliant technical documentation
• DMS management
• Monitor compliance with applicable standards, certifications, and customer requirements
• Information of management in the case of changes in the standards, which have relevant influence on the company
• Conduct the supplier quality management
• Maintain the QMS and product compliance to applicable regulations and standards
• Maintaining familiarity with company product ranges
• Identifies quality system improvements when gaps are identified through audits and departmental reviews
• Entire Market access registration

• A minimum of 3 years experience in quality management in the field of industrial production, international regulatory and risk management of medical devices
• Strong knowledge of, ISO 9001, ISO 13485, MDR, MDSAP (ISO 14971, ISO 10993 advantage)
• Strong analytical skills with the ability to interpret quality data and identify trends for continuous improvement
• Strong communication skills for cross-functional collaboration and audit readiness
• Good Hands-on practice of maintaining Quality Management Systems
• Fluent in English and French (German advantage)
• Ability to travel 10-15% domestic and international

You can expect an extremely interesting working environment with challenging tasks in an international environment in which you can develop your area of responsibility and contribute your ideas.