Senior Quality Engineer

13 hours ago


Bedfordshire, United Kingdom TEC PARTNERS LIMITED Full time

Senior Quality Engineer

My client, a forward-thinking market leader who are recognised for the design and supply of advanced consumer diagnostics products. Committed to advancing personal health and well-being through new and innovative products while providing accurate, reliableand simplistic diagnostics across the globe. Not only are these features utilised and appreciated by consumers, but doctors working in family medicine.

Senior Quality Engineer Role:
As Senior Quality Engineer you will be responsible for ensuring the Quality Management System ism maintained to comply with company, quality and regulatory requirements. Managing Key Performance Indicators (KPI's) in relation to innovation, provide supportto external audit activities and identify improvements throughout the business in conjunction with stakeholders. Not only will you assist manage the current QMS, but you will also identify key technical challenges as well as partake in risk analysis movingforward.

Senior Quality Engineer Requirements:

- Degree or equivalent or 5+ years' experience working within the medical device sector
- Knowledge of ISO 13485 and US FDA FDA 21 CFR 820
- Experience in the design and development in the medical device industry
- Excellent communication skills
- Proven ability to build strong relationships

Senior Quality Engineer Desirables:

- EU IVD Directive or EU MDD directive
- Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746
- MDSAP

This is a fantastic opportunity to join a reputable and well established household name where you will be granted the opportunity to develop, learn and further your career in a fast paced quality setting. On offer is competitive salary options and an extensivebenefits package.



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