BDI Continuous Improvement Leader

Overview: BDI Continuous Improvement Leader Location:  any BD manufacturing or design site Travel:  40-60% This position provides coordination of quality projects at the BDI Quality Assurance segment level staff and across Business Units and associated manufacturing sites within the BDI segment. This position provides primary oversight and administration of the BDI segment level quality management system, product root cause investigation review, and quality system integration between legacy Bard systems and global BD quality systems. Summary of Position with General Responsibilities: Maintain quality and regulatory expertise to provide guidance and interpretation of FDA and health authority regulations. Assist in developing implementation strategies at the BDI segment level in accordance with these regulations. Provide guidance and review for BDI segment of compliance decisions and actions including field actions, responses to regulatory citations (i.e. warning letter, 483's). Participate in the development of solutions for BDI segment, BU and Site Quality System problems and/or non-compliance on ad hoc basis. Coordinate continuous improvement of the BDI Quality System and facilities. Act as coordinator of key BDI segment level CI projects affecting multiple BUs. Coordinate the review of BDI segment standards and policies, integrating the legacy Bard CQA standards into BDx level policies and procedures Responsible for maintenance of the BDI Quality department budget, including support of remediation projects at BDI BUs. Coordinate, consult or assist the QMS team, as needed, on problems, projects or issues to implement an effective processes or solutions. Maintain an up to date knowledge in the areas of quality assurance, regulatory compliance, design controls, risk management, and statistical techniques. May perform other duties as needed and/or assigned. Essential job Functions: Additional Skills and Competencies Required: Strong presentation skills and ability to present material and complex matters in a succinct and organized manner Demonstrated ability to effectively work across various functions in order to ensure deliverables are met against required timelines. Ability to quickly establish credibility, trust and support with both internal and external constituents. Demonstrated ability to hire, develop, and manage associates. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures and governmental regulations Strong ability to communicate effectively with leaders at the most senior levels within the corporation. Strong quantitative, modeling and negotiations skills and experience. Ability to travel within the USA and internationally Key Relationships: Internal Relationships:  Corporate functions and officers Business Unit Senior level leaders for BDI Segment across all functions External Relationships: Senior level officials from external or supplier companies Outside legal counsel Project management and financial consultants Basic Qualifications: Must have 15years of Quality System (QSR and ISO 13485) management experience Must have 10 years of medical device experience (class II/Class III) Must have 5 years of managerial experience Strong working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable regulations. BS Degree in Science or Engineering or equivalent. Master's Degreepreferred. Education and/or Experience: BS Degree in Science or Engineering or equivalent. Master's Degreepreferred. Job ID 2018-12435
Salary Range: NA
Minimum Qualification
15+ years

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