QA Consultant/Manager
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A leading medical devices organisation is seeking to recruit a QA Consultant/Manager to their office in Switzerland. This historic organisation prides itself on over 70 years of working in the global hearing care market by offering comprehensive solutions to treat all forms of hearing loss. This vacancy is an exciting opportunity to work with an establishment that aims to become the most recognised and innovative leader in the hearing care field.
Job Responsibilities:
- Designing and developing within quality management system.
- Ensuring compliance for all applicable regulations within medical device industry (ISO13485, FDA, MDR, CFDA, KFDA, Health Canada, etc.).
- Analysing current procedures regarding regulatory gaps.
- Supporting writing procedures, work instructions and other quality documentation according to internal guidelines.
- Overseeing business process management notation (BPMN) knowledge is a plus.
- Driving quality process improvement (CAPA).
- Ensuring defined deliverables for DHF, DMR within projects.
- Providing Quality Assurance for development projects.
Skills and Requirements:
- Bachelor/ Master in engineering (hardware & software), or related discipline with further education in quality.
- Experience working in a similar position in a medical device environment.
- Excellent German, English is a plus.
- Quality management for R&D (Hardware & software).
- Good knowledge regarding DHF, DMR.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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#Compliance/Quality
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