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Job #02834

About our client Our client is a leading medical device company specialized in ophthalmology and eye care products. They have over 13,000 employees globally and a reputation as a leading innovator in the field. With operations in 36 countries and a 150-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Senior Supplier Quality Assurance Specialist New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct supplier audits, qualify new suppliers and monitor the performance of current suppliers 2) Implement and maintain the effectiveness of the Supplier Management Quality System 3) Develop and execute (to a supplier audit schedule) quality systems, audits of suppliers, contract manufacturers and contract service providers 4) Develop audit plans and make associated communications with supplier as well as relevant functions 5) Monitor and approve supplier CAPA plans and activities to closure, including objective evidence of effectiveness 6) Work with Design and Development, Manufacturing and Purchasing when qualifying and monitoring supplier performance 7) Monitor the global approved supplier base to ensure that the status of the suppliers is correct 8) Work with suppliers (as needed) to ensure that their performance is acceptable as per site requirements 9) Analyze supplier information and present supplier metrics to appropriate functions and levels of management Requirements 1) Bachelor’s degree in Engineering or a technical discipline 2) Minimum 5 years of experience in manufacturing, engineering design, QA or regulatory assurance roles 3) 2+ years of supplier QA experience (auditing of suppliers) in the device or pharmaceutical industry 4) ISO Lead Auditor certification 5) ASQ CQA or equivalent preferred (or experience in internal/external auditing) 6) Expertise in ISO –13485/ISO 9001, 21 CRF 820, 211 and 210 as well as medical device directive quality system requirements 7) Ability to handle supplier audit situations and interactions in a tactful, professional and effective manner 8) Ability to manage and prioritize multiple tasks 9) Experience in using computer programs (MS Word, Excel and Access) 10) Ability to communicate well (both written and oral) with external and internal customers 11) Willingness to travel – up to 40%