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Senior Supplier Quality Engineer - Bardi, Italia - Mozarc Medical
Descrizione
Thursday, December 7, 2023About Mozarc Medical
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology.
Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do.Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease.
Find your purpose and passion at Mozarc Medical.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 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 Nice to Have: 4+ years of supplier quality engineering experience in the medical device industry delivering dialysis products ASQ CQE 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 :
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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