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Quality Specialist – Neuenburg | JobRevolt

Über den Job

Bioptron AG, part of the Zepter Group since 1996, is a Swiss company developing and manufacturing medically certified light therapy devices. The company invests in sophisticated research and new product development to achieve optimal clinical effectiveness of light therapy treatments.

Aufgaben

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 by 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 from product realization
Main responsibility for installation and updating of compliant technical documentation
DMS management
Monitor compliance with applicable standards, certifications, and customer requirements
Inform management of changes in standards that 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
Identify quality system improvements when gaps are identified through audits and departmental reviews
Lead entire market access registration

Profil

Minimum 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

Rahmenbedingungen

80% - 100%
Location: Neuchâtel
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

Quality Specialist

Über den Job

Über den Job

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Rahmenbedingungen

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