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BD (Becton, Dickinson and Company) Manager. Quality Systems in Columbus, Nebraska

Job Description SummaryEnsure compliance to all Quality System Requirements. Manage the quality activities and personnel for designated areas in the plant. Coordinate efforts for training, non-conforming material investigations, and internal/external audits. Assure manufacturing and support areas are compliant to regulations, standards, and internal procedures. Support validation and continuous improvement activities for manufacturing and quality systems. Provide regular updates to management of trends from these areas and oversee supplier quality activities.

Job Description

  • Oversees the plant internal auditing function to assure compliance with all company and segment guidelines and government and regulatory requirements.

  • Directs resources in the performance of audits of Quality Assurance/Manufacturing documentation and systems for compliance with, ISO 13485 and ISO 17665, including the development and maintenance of policies and procedures and publishing of effective and objective audit reports, coordination and review of audit responses and subsequent verification of corrective and preventive actions.

  • Responsible for the maintenance and reporting of local and division metrics to management.

  • Supports the management of the electronic documentation system (ECoMs) to ensure that documentation is maintained and available at points of use throughout the site, as well as the administration of the Engineering Change Order (ECO) system to assure procedures and specifications comply with pertinent Corporate, Division and regulatory agencies.

  • Responsible for assuring compliance with all applicable federal, state, local, regulatory and company requirements.

  • Supports continual improvement efforts in regards to documentation collection, retention and incorporation into Devise History Records and process documentation for product lines.

  • Also responsible for the maintenance and reporting of local DHR metrics to management.

  • Utilizes and directs Six-sigma improvement projects in continuous improvement of processes and overall departmental performance in meeting departmental and division goals and metrics.

  • Responsible for the document retention area and management of entry and disposal of stored documents.

  • Maintain full compliance with FDA Quality System Regulations (21 CFR Part 820) as well as all applicable International Standards (i.e. ISO 13485, GMPs, etc.) and BD Policies and Procedures.

Supervision:

  • This position will supervise two direct reports

Requirements:

  • Bachelor of Science degree in Engineering or Science related field.

  • Minimum 5 years experience in quality, with a minimum of 3 years in the medical device industry

  • Experience with SAP preferred

  • Experience in Lean/Six Sigma preferred

  • ASQ CQA, CQE, CMQ/OE preferred

  • Computer proficiency in Microsoft Office (Word, Excel, Power Point, Outlook)

#LI-PRO

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.

Primary Work LocationUSA NE - Columbus (West)

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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