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Form of work
SalaryStem Recruitment are recruiting a Senior Quality Engineer for a life sciences company based in Edinburgh. Reporting to the Senior Manager of Quality Systems, this role will support the maintenance of our ISO 13485 certification through all aspects of the quality management system. The role will be the quality lead on internal new diagnostic development projects and will work with project leads to ensure compliance with internal procedures and that technical investigations are conducted to the highest standards.
The role will support the teams define quality strategies and managing design history files. You will lead on method & equipment validation as required, provide quality training and drive continual improvement both within quality systems and across the diagnostics department.
Expertise:
- Detailed knowledge and experience of working in accordance with ISO 13485
- Experience of supporting new diagnostic product development from early concept to formal verification and validation phases.
- Highly experienced validations of equipment, methods and software
- Working knowledge of ISO 14971 risk management procedure and its application to new product development.
- Excellent understanding of Quality requirements as they apply to R&D and New Product Development for diagnostics.
- Experienced in Conducting Internal & External Audits.
- Good understanding of the Regulatory landscape as it pertains to IVD in UK, EU and US would be desirable.
- Significant experience of CAPA management.
Qualifications:
Education/Qualifications
- Educated to degree level (preferably in a Science related subject) or equivalent
