Sr. Supplier Quality Compliance Specialist

The Sr. Supplier Quality Compliance Specialist is responsible for providing leadership and guidance to the supplier management programs within the Surgery Business Unit (BU) to ensure compliance with established corporate standards and regulated agencies (ISO, FDA, and others as applicable). Responsible for the planning, development, and implementation of quality systems that support the Surgery organization in the successful management of suppliers. This position is key in developing the compliance strategy for Surgery and represents Surgery in the BD Corporate initiatives.Primary Responsibilities:Management of all suppliers providing products/services to the Surgery BU Warwick and Vernon Hills Design Centers, including maintaining the Approved Supplier List (ASL), leading the Governance Board, and Quarterly Supplier Quality Review Meetings for both Design Centers.Providing Supplier Management Oversight of the Surgery BU manufacturing sites to ensure compliance and alignment to regulations and industry standards.Review and maintenance of all Quality Agreements.Maintain communication with Regulatory to assure accurate identification of critical and crucial suppliers.Coordinate the completion of Supplier Surveys/Assessments across Surgery business unit sites.Work with Procurement/Sourcing during supplier selection to provide quality-related input for potential suppliers.Monitor status of Supplier Change Requests.Support supplier audits and improvement projects.Develop Supplier Annual Monitoring Plan (SAMP) across Surgery business unit sites.Provide support / actively participate in internal and external audits (FDA, ISO, Corporate, and Internal).Provide guidance to new product development teams related to supplier capabilities, quality agreement, supplier technical expertise, and overall ability of supplier to meet business needs.Work with Corporate project teams to coordinate and implement supplier quality initiatives across Surgery business unit sites.Provide guidance on documentation associated with supplier qualification and supplier-driven changes including supplier validations, supplier quality agreements, process controls, and compliance to regulations and industry standards.Periodically assess suppliers and Supplier Quality team practices to ensure global regulatory requirements are met.Other projects and duties, as assigned.Required Qualifications:Change Control and Supplier Management experience in a manufacturing environment, preferably in a regulated industry (medical, automotive, aerospace, or similar).Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.Strong organizational skills.Strong working knowledge of statistical quality tools and statistical process control (SPC).Strong oral and written communication skills; strong interpersonal skills.Preferred Qualifications:Knowledge of Design of Experiments.Manufacturing background preferred (knowledge of FMEA, Control Plans, Measurement System Analysis (MSA), First Articles, Validation – IQ/OQ/PQ).Ability to analyze manufacturing and quality systems and provide recommendations for improvement.Familiarity with Production Part Approval Process (PPAP).Education and Experience:Minimum of a bachelor’s degree in a technical field required (e.g., Engineering, Science, etc.).Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.Strong working knowledge of QSR, ISO 13485, MDD/MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.Experience conducting quality audits (internal and supplier).Industry Certification (e.g., ASQ CQE, CRE, CQA, CQM) preferred.For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. It’s also a place where we help each other be phenomenal, we do what’s right, we hold each other accountable, and learn and improve every day.To learn more about BD visit

bd.com/careersPrimary Work Location:

USA RI - WarwickWork Shift:

NA (United States of America)

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