Quality Specialist

• 28 août 2026
• 80 - 100%
• Indefinite duration
• German (Intermediate), English (Fluent), French (Fluent)
• Route des Gouttes d-Or 30, 2000 Neuchâtel
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BIOPTRON AG, SWITZERLAND

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

Since its creation in 1988, BIOPTRON® has become a global brand synonymous with innovative medical products, unmatched in prevention, treatment and recovery for various medical conditions. BIOPTRON AG continues to invest in sophisticated research and development of new products necessary to achieve optimal clinical efficacy of light therapy treatments.

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

Functions and responsibilities

• Development and implementation of the quality management system (QMS) within BIOPTRON AG (ISO 13485, MDR, MDSAP)
• Assistant to the quality management representative & PRRC
• Ensure that the QMS is complete, accurate and compliant to support inspections and audits
• Collaborate with other departments to support quality-related processes and procedures
• Provide quality management support on projects
• Support and assist the company during external audits and inspections, for example Notified Bodies or Competent Authorities
• Lead all QMS processes, including, but not limited to: management review, CAPA, risk management, change management
• Supervise the quality of records resulting from product realization
• Primary responsibility for the installation and updating of compliant technical documentation
• DMS management
• Monitor compliance with applicable standards, certifications and customer requirements
• Inform management in case of changes to standards having a relevant influence on the company
• Conduct supplier quality management
• Maintain the QMS and product compliance with applicable regulations and standards
• Maintain good knowledge of the company's product ranges
• Identify quality system improvements when gaps are detected during audits and departmental reviews
• Full management of market access records

Qualifications

• Minimum 3 years of experience in quality management in the field of industrial production, international regulation and medical device risk management
• Solid knowledge of ISO 9001, ISO 13485, MDR, MDSAP standards (ISO 14971, ISO 10993 is an asset)
• Excellent analytical skills with the ability to interpret quality data and identify trends for continuous improvement
• Excellent communication skills for cross-functional collaboration and audit preparation
• Good operational practice of maintaining quality management systems
• Mastery of French and English (German is an asset)
• Ability to travel 10-15 % nationally and internationally

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