Supplier Quality Engineer Mirandola

Supplier Quality Engineer
Mirandola
Emilia Romagna, Mirandola

Join us today and make a difference in people's lives! Are you passionate about driving excellence and ensuring top-tier quality in the supply chain?

As a Supplier Quality Engineer (SQE), you'll be at the forefront of innovation and collaboration, working with supply chain partners to enhance processes, exceed customer expectations, and deliver products of unmatched quality. This role offers a dynamic blend of technical expertise, supplier development, and process improvement, making a tangible impact on customer satisfaction and business success.

If you're ready to lead the charge in shaping quality excellence, we'd love to have you on our team!

Duties and Responsibilities Ensure that specifications cite critical characteristics and required process controls. Provide technical development of the supplier throughout the product development process to assure launch readiness, including development and approval of supplier control plans (process validation requirements, sampling requirements). Establish incoming inspection plans for components with the supplier & LivaNova R&D department, assemblies and/or finished devices and quality department. Assure the suppliers understanding of LivaNova products, their intended use, and regulatory requirements. Ensure the proper risk controls are implemented at both supplier and LivaNova. Ensure the measurement system at supplier & LivaNova are identical, and/or capable. Monitor and analyze supplier data internally and externally gathered to identify trends and prevent potential problems. Manage the Control and Manufacturing Process Change with the suppliers. Initiate and manage Supplier Corrective Actions (SCAR) in partnership with Manufacturing/Process Engineering and Quality Engineering to ensure complete and effective root cause analysis and corrective action implementation is performed promptly. Proactively identify and help implement improvement to supplier quality and supplier quality tools and processes. Collaborate with other members of the supply team to establish and maintain a meaningful supplier quality scorecard which is part of a bigger supplier scorecard that includes delivery, cost, partnership, etc. Manage the supplier quality audit process, which includes establishing requirements, setting priorities, determining audit frequency, and performing audits in a lead auditor role. Support purchasing for new supplier qualification program. The Individual Degree in Engineering or equivalent qualification with extensive experience in manufacturing processes. Strong understanding of FDA, GMP, ISO 13485, and ISO 9001 standards is desirable. Fluent in Italian and English, both written and spoken, is mandatory. Proven experience in a similar role with a good understanding of manufacturing best practices. Excellent communication and negotiation skills, with the ability to collaborate effectively across internal teams and external suppliers. Capable of thriving in a complex, matrixed, and geographically diverse environment. Proficiency in advanced computer tools and statistical/data analysis software (e. g. , Minitab). Willingness to travel up to 25% as required.

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