Experienced QA Specialist Medical Devices
My client is a well-established and growing international healthcare and medical device company.
Due to this growth, my client is looking for an experienced QA Specialist with Medical Device and Healthcare experience and international experience to join their team in the Vaud canton.
The person will be responsible for providing control over quality for all company’s product in Switzerland and Europe to ensure that the appropriate standards for quality are maintained to reach customer’s reliability.
- Support processes from a Quality standpoint
- Document and Record Control, in particular write and/or review SOP, WKI, FORM for Quality-related processes and support other departments in regards to the writing and/or review of the SOP, WKI and FORM for other processes
- Management Processes, in particular the compilation of relevant information and the preparation of management reviews and quality objectives
- Internal Communication on quality-related matter
- Supplier Lifecycle, in particular the identification and assessment of quality-related requirements, as well as the monitoring of suppliers
- Design & Development, in particular the coordination of change management and the support from a quality standpoint to design & development projects
- Verification Activities
- Customer-Related Process, in particular regarding enquiries management
- Product Identification & Traceability
- Equipment & Infrastructure Management, in particular for Monitoring and Measuring devices
- Audit Management, for internal and external auditing activities
- Performance/Analysis of Data
- Performs other related duties as assigned.
Your profile :
- University degree
- Experience with ISO 9001 and ISO 13485 standards
- Training on regulations regarding life science/healthcare products (pharmaceuticals, medical devices and/or cosmetic products)
- 3-5 years’ experience in technical and quality affairs with interpretation and application of standards/current industry practices
- Experience in internal and supplier auditing / inspection
- Experience in project management as project manager and team member
- Strong interest in technical affairs regarding production and quality control
- Full capacity to assess the product quality
- Must be fluent in English (both written and spoken)