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| Job Title | Location | Salary | |
| Quality Engineer | EU | Not Disclosed |
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| Quality Systems Manager | EU | Not Disclosed |
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Quality Systems Engineer Career Profile
Quality Systems Engineer
A Quality System is responsible for the design, implantation and maintenance of Quality Systems in a medical device company.
Role/Responsibilities
- Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
- Represent EMEA on global quality initiatives
- Liaise with EMEA manufacturing sites and subcontractors
- Drive and implement Quality System Improvements Perform audits of subcontractors
- Perform internal audits
- Support external audits
- Manage CAPA and Event Investigations for site
Skills/Experience
- Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
- Attention to detail and accuracy - essential
- Ability to work well under deadlines and pressure
- Problem solving skills for developing creative solutions and meeting objectives are required
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
- Excellent analytical ability
- Communication skills
- The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.