Senior Supplier Quality Engineer

Senior Supplier Quality Engineer   A Day in the Life   You will be an individual contributor in the  Supplier Quality Organization for the management of suppliers within the Quality Team together with Manufacturing Team with accountability on Support the evaluation and selection of global best-in-class suppliers through the application of appropriate tools and measurements Develop a strong relationship with the Suppliers Prepare and negotiate Quality Agreements with suppliers Apply process development and materials knowledge to component development and quality issues Review supplier processes and equipment for optimum output, yield and process stability Develop and implement supplier improvement programs, which may lead to certification of suppliers/components Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes  Review and approve changes to the specifications for purchased materials used in production and manage the supplier change execution process with the supplier in partnership with Sourcing Engineering Develop and maintain controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals Analyze and identify trends from quality data and develop proactive measures with suppliers in support of continuous improvement Maintain and Coordinate company's supplier audit schedule and lead or participate in the audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements As appropriate, institute appropriate root cause corrective actions relating to production defects and monitors for desired results Maintain approved supplier files Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485, AIMD R-PAL) and company Quality System procedures Function effectively as part of cross functional and at times cross organizational teams Develop strong partnering relationships with Supply Chain, R&D, Operation Quality, and Manufacturing Engineering groups Guide the successful completion of major programs and, as required, functions in a project leadership role Participates in supplier change control ensuring all design control evidence is complete and accurate  Must Have: Bachelor’s degree in engineering, science or technical discipline 4 years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise Fluent in English  PC skills, MS Office (Word, Excel, Power Point)   Nice to Have: 4 years of supplier quality engineering experience in the medical device industry delivering dialysis products  ASQ CQE certification ASQ Lead auditor certification  Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigations techniques, statistical quality control, protocol/report preparation and non conforming product controls Advanced use and understanding of statistical tools  Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485   Additional Info: Work location: Tovo Sant’Agata /Italy