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Design Quality Assurance

Michael Page
Contratto a tempo indeterminato
    Multinational Public Listed Company that delivers design, engineering, manufacturing, real-time supply chain insight and logistics services to companies in the Healthcare Market The Design Quality Assurance will be based in Milano. The Design Quality Assurance Engineer is responsible for ensuring that all processes and systems conform to customers and internal quality system requirements (i.e. design control) are properly applied to projects in order to achieve coordinated results from all the areas involved Guide design team in conformance to the FDA's QSR, ISO 13485 Serve as lead and coach in the implementation of design control requirements per above standards. Work within the design team to ensure that standard operative procedures are correctly used and maintained during the product development. Ensure the implementation of Risk Management activities during the product development. Ensure that project data and documents are managed according to document and change control procedure Act as Agile change analyst Record and fill in relevant documents for QA. Supporting customers in quality assurance activities. Participates in ISO Certification and surveillance audits and customer audits. Perform Internal Audit (QMS and project audit) Cooperate with the design team to define test methods and procedures Oversee testing activities) Requirements A degree in Engineering (Mechanical, Electrical) or equivalent combination of education, experienceA minimum of 3 years of QA relevant experience; A broad theoretical understanding and practical knowledge of Quality Assurance process/techniques in Product Development The know how in quality engineering theory and practices, know how in statistical processes and reliability; Soft skills: good communication skills, to be flexible and motivated and to have a high level of commitment to the success of the project; Languages: English - business fluent. Available to travel for the 10% of the time Nice to HaveExperience in project management Italian speaker
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