The role
03We are looking for an experienced Quality Specialist (80% - 100%) based in Neuchâtel Duties And Responsibilities
01Further development and implementation of quality management system (QMS) within BIOPTRON AG (ISO 13485, MDR, MDSAP)
02Deputy to the Quality Management Representative & PRRC
03Ensures that the QMS is thorough, accurate, and compliant to support inspections and audits
04Collaborate with other departments to support quality related processes and procedures
05Provide Quality Management support on the projects
06Support and assist the company during external audits and inspections, Notified Bodies or Competent Authorities
07Lead entire QMS processes for instance, and not limited to: Management Review, CAPA; RISK; Change Management
08Supervising quality of records form product realization
09Main responsibility for the installation and updating of compliant technical documentation
10DMS management
11Monitor compliance with applicable standards, certifications, and customer requirements
12Information of management in the case of changes in the standards, which have relevant influence on the company
13Conduct the supplier quality management
14Maintain the QMS and product compliance to applicable regulations and standards
15Maintaining familiarity with company product ranges
16Identifies quality system improvements when gaps are identified through audits and departmental reviews
17Entire Market access registration
