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BD (Becton, Dickinson and Company) Quality Assurance Manager in Carol Stream, Illinois

Job Description SummaryResponsible for the general management of the Bard Brachytherapy, Inc. (BBI) Manufacturing Quality Assurance function to ensure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA). Responsible for the planning, development and implementation of quality systems that support the BBI Manufacturing site objectives and resources.

Job Description

Responsibilities:

  • Serve as Quality Manager for all operations activities.

  • Supervise the Quality Inspection, QC Shipping/Receiving and Calibration Departments.

  • Supervise operations quality engineers.

  • Coordinate inspection activities to insure product and process compliance to acceptance requirements.

  • Control nonconforming product and coordinates final product acceptance/release activities.

  • Oversee operations quality involvement in process validation activities.

  • Develop, implement, and maintain quality systems to ensure FDA and ISO compliance.

  • Assist and/or lead the migration of the BBI quality system from on BD division to another.

  • Optimize quality systems to effectively identify, measure and reduce cost of quality activities.

  • Identify, support, and develop departmental resources to achieve business and quality objectives.

  • Actively participate in all facility audits (FDA, ISO, Corporate and Division).

  • Participate in the development of process FMEAs.

  • Review and approve all engineering changes for existing product, processes, and materials.

  • Promote and support multi-discipline teamwork.

  • Oversee establishment of manufacturing quality plans for transferring product designs to manufacturing.

  • Maintain calibration system and associated activities.

  • Manage the Material Review Board process.

  • Support existing product/process improvement programs.

  • Support new product development programs.

  • Hire and develop Quality resources at BBI.

Required Qualifications:

  • Process validation experience, including packaging and labeling processes.

  • Technical knowledge of measuring equipment and the required calibrations.

  • Strong working knowledge of QSR, ISO 13485, MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.

  • Experience conducting quality audits (internal and supplier).

  • Experience managing and hosting external audits (e.g. FDA, ISO).

  • Strong organizational skills.

  • Strong working knowledge of statistical quality tools.

  • Strong oral and written communication skills.

Preferred Qualifications:

  • ASQ Certification (CQE, CRE, CQA, CQM) preferred.

Education and/or Experience:

  • Minimum of a four-year degree in an Engineering discipline. Mechanical or Biomedical Engineering degree preferred.

  • Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.

  • Minimum 5 years supervisory experience.

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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Primary Work LocationUSA IL - Carol Stream

Additional Locations

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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