Quality and Compliance Engineer (Medical)

Recruiter
Enterprise Recruitment
Location
Lowfield Heath, UK
Salary
Competitive
Posted
20 Aug 2019
Closes
23 Aug 2019
Ref
1237967371
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Quality and Compliance Engineer (Medical) Working for an expanding medical technology supplier, you will work as a Quality and Compliance Engineer taking responsibility for the support and promotion of Quality assurance and regulatory affairs supporting overall compliance. The position will provide quality assurance input and guidance to cross functional teams ensuring compliance to ISO13485, FDA standards. This is a great opportunity to join a rapidly growing organisation on a great journey who are slowly becoming industry leaders in their specialised field. You will work with manufactures and suppliers to ensure problems are effectively resolved and improve the quality of products and services supplied to the company and their customers. This role will involve all stages of the product life cycle and proven experience will be required in new product development and quality engineering in the medical device sector. This is a varied role with great prospects if you are keen to find out more send your CV to tom@enterpriserecruitmentDOTcom or feel free to call in. Other responsibilities will include: Ensuring conformance to regulatory requirements to ISO 13485, 14971, ISO 62304 and 21 CFR part 820. Ensure all new products meet customer requirements. Provide support and direction on all quality and compliance matters working closely with internal project and design teams. Take ownership of product safety, usability, risk management, compliance and product performance. For this role you will need: Experience of working as a Quality engineer within the medical device sector. Strong working knowledge of ISO 13485 and FDA 820 part 21 standards and regulations. Excellent communicator at all levels. Experience with auditing

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