Medical Devices Quality Assurance Assistant
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Job Type | Permanent Full Time |
Location | Cambridge |
Area | Cambridgeshire, England |
Sector | Scientific |
Salary | £25000.00 - £30000.00 per annum |
Start Date | ASAP |
Job Ref | J2109 |
Job Views | 221 |
- Description
- Due to internal progression within their business, our client located on the rural outskirts of Cambridge is now seeking to recruit a Quality Assurance Assistant (Medical Devices) to join their growing team framework.
You will be joining a company at the cutting edge of scientific advancement in healthcare and operate under an ISO 13485 certified quality management system and an ISO 27001 information security management system.
As a Quality Assurance Assistant, you will be working directly with the Senior Quality Assurance & Regulatory Manager in a variety of exciting and diverse projects. Due to the nature of this work you will not only be able to pay particular attention to detail but also have a methodical and analytical approach to each task you undertake. You will have excellent observation skills as you will be required to monitor and observe working practices to ensure standards are being met.
Main Responsibilities
*Managing department reports including company quality objectives and communicating these company-wide
*Managing the timely reporting of non-conformities and CAPA Management
*Managing review of new and existing suppliers
*Preparation of quality assurance documentation
*Assisting with risk management activities
*Assisting in managing project plans, design and development files and medical device files
*Assisting in internal and external audits
*Assisting with completion of technical and regulatory documentation
It is essential that you have ISO 13485
Qualifications
* Bachelor's degree in Science related subject (Biology/ Genetics/ Bioinformatics/ Software preferred) or equivalent work experience
Knowledge, Skills & Abilities
* Working knowledge of Microsoft Word, Excel and PowerPoint
Related Experience
* Experience of working with ISO 13485 quality management systems
* Experience of dealing with non-conformities and CAPA management
As well as a good basic salary, the company offers a very generous annual bonus (company performance based)
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