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BD (Becton, Dickinson and Company) QMS Manager in Vernon Hills, Illinois

Job Description Summary

Job Description

Oversight of the Quality Management Systems which will support the compliance of BDI Surgery. This position establishes, directs, and ensures that the management of all Documentation, Compliance Training, Situation Analysis, and CAPA activities are in compliance with FDA Quality System Regulations (QSRs), ISO 13485, EU MDR, and other international regulations that apply to the products manufactured by BDI Surgery. This position will be responsible for monthly reporting of quality metrics and in the preparation of management review for the division board as well as BD Executive Management Review.

Essential Duties and Position Responsibilities

  • Develop and improve quality systems to facilitate business and quality objectives and compliance review; ensure that the organization is alerted to issues in time to resolve potential adverse effects on the customer, company, or business.

  • Lead Quality System functions to support quality system design and implementation for compliance with government regulations and international standards requirements commensurate with the BD way.

  • Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department including Document Control, Training, and, CAPA.

  • Maintains the integrity of the Documentation Systems and associated documentation.

  • Maintain the training program, including job position requirements, and evidence of training completion for employees.

  • Maintain the CAPA system, including investigations, corrections, corrective and preventive actions, and effectiveness verifications.

  • Responsible to meet quality objective goals as defined and for reporting monthly and quarterly metrics to senior management.

  • Has an in-depth knowledge of the EDM, training, and CAPA systems.

  • Provides training on the Documentation, Training, and CAPA systems and associated policies and procedures.

  • Develops the CAPA Board meeting schedule, meeting presentations, actions, and minutes.

  • Facilitates and ensures CAPA closures to meet due dates.

  • Responsible for the execution of Situation Analysis and Field Actions.

  • Serves as a QA representative in developing and maintaining Business Unit Policies and Procedures.

  • Interfaces and responds to regulatory agencies, as necessary.

  • Prepare and manage annual budgets in areas of responsibility.

  • Participates in the development and application of new quality systems programs for integration into BDI Surgery.

Qualifications, Knowledge, and Skills Required:

  • Strong listening, assessment, questioning, analytical and problem-solving skills

  • Knowledge, understanding and interpretation of FDA regulations, ISO standards, and other industry standards for medical devices

  • Demonstrated successful interactions with regulatory agency and Notified Body representatives during audits and product submissions.

  • Demonstrated success in the development and application of progressive quality systems to the development and ongoing supply of medical devices (Class II and III preferred).

  • Thorough working knowledge of all major global quality system requirements (FDA, EU, MDSAP at minimum) for medical devices.

  • Good knowledge of Statistical techniques, investigation techniques, Quality Assurance principles, team functions, leadership techniques and project management methodologies.

  • Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, and team building

  • Ability and experience in global travel. Ability to accommodate travel as needed.

EDUCATION/EXPERIENCE

  • BS degree required in Engineering, Science, or Technical field; higher education a plus.

  • Minimum of 10 years’ experience with an FDA regulated industry

  • Minimum of 5+ years supervisory experience

  • ASQ, CQE, and CQA Certifications preferred

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

#LI-PRO

Primary Work LocationUSA RI - Warwick

Additional LocationsUSA IL - Vernon Hills

Work ShiftNA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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