Quality Specialist

Quality Specialist

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

Duties And Responsibilities

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, 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

Qualifications

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. jpidca7820ejm jpit0835jm jpiy26jm