Radiometer Basel AG is a Medical Device company focused on the development and production of high tech systems in the field of non-invasive blood gas monitoring. Radiometer Basel AG is located in Basel, Switzerland and is part of Radiometer, the world leader in development, manufacturing and distribution of technologically advanced Acute Care testing solutions.
For the Quality group at Radiometer Basel AG, we have an open position for a motivated and well organized person with a lot of initiative who has immediate or short term availability for a temporary opening for one year.
Your general responsibilities
Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
Assist in preparation for and conducting of regulatory agency inspections
Manage daily complaint evaluation
Perform statistical analysis of complaint rates for a number of products.
Authoring of investigation reports and other documentation. Ensuring that complaint documentation is complete and aligns with the regulatory requirements.
Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, correction, corrective and preventive actions and effectiveness checks.
Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency.
Ensure CAPA documentation meets Good Document Practices and is a complete and accurate record of CAPA actions.
Identify and execute recommended quality improvements.
Maintenance of Validation Master Plan; planning of process re-validations
Support of process validations and equipment qualifications
Support of process risk analyses
Bachelor Degree or equivalent in Engineering, Pharmacy, Biology, or Biochemistry or the like
Thorough knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards such as US FDA Quality System requirements, ISO 13485:2003, ISO 14971 (Risk Management) requirements, Medical Device Directive (MDD) requirements.
Proficient in the management of CAPA process, both in individual cases and system
Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
Understanding of software, electrical and mechanical engineering principles
Excellent verbal and written communication skills
Effective problem solving skills
Project management skills and experience.
Proficient in timely review of technical data.
Used to work in cross functional teams, projects
Experience with work relations in different cultures.
Be proactive and be able to finalize tasks within deadlines.
Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
Very good knowledge of German and English (business fluent)
You are familiar with:
FDA, Health Canada and Japan QMS
GHTF Validation guideline
Risk Management ISO 14971
Statistical Process Control SPC
GDP (Good Documentation Practices) and GTP (Good Test Practices)
Small dynamic group dedicated to advanced technology
A multidisciplinary and international environment
Opportunities for continuous development in Radiometer
If you are independent, strong in planning and execution and prefer a “hands on job”, we are looking forward to receiving your Resume/CV.