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BD (Becton, Dickinson and Company) Associate Manager Quality, Compliance in Broken Bow, Nebraska

Job Description Summary

Job Description

Summary

Responsible to the Plant QA Manager for the management of the plant documentation system, internal audits, corrective/preventive actions, diagnosis of chronic quality problems and quality trend analysis. Supports the plant in the identification and resolution of quality assurance and regulatory issues related to product lines to assure compliance with FDA regulations, ISO standards, Corporate directives and Company strategies.

Minimal travel is required with this position.

Job Description

  • The essential functions of this position include but are not limited to:

  • Develop and maintain a system to define, track and trend all quality metrics (e.g. Complaints, Notifications, CAPA’s, Audits, etc.)

  • Develop and implement improvement plans around quality and efficiency based on the outputs of quality performance metrics.

  • Serves as the regulatory compliance coordinator for the plant. Meets and escorts Federal regulatory agency inspectors, such as: FDA and ISO.

  • Be familiar with the products manufactured as well as the manufacturing process to assure compliance to Federal Regulations and International Standards as required.

  • Manages the plant's internal audit program, and corrective/preventive action system to ensure compliance with Federal Regulations and International Standards where appropriate. Assists the QA Manager in all external audits of Broken Bow.

  • Assists Quality Assurance personnel in addressing quality issues as appropriate.

  • Works with other departments to maintain the highest quality standards.

  • Responsible for the activities and programs as defined for this position in the Quality.

  • Systems Policy Manual.

  • Directs attention to the career pathing and development of all direct reports while working to develop technical expertise and managerial/supervisory competency.

  • Manages the plant training program

Qualifications

  • Bachelor's Degree required

  • Minimum of 3 years working in a quality role within a manufacturing environment.

  • Minimum of 2 years of supervisory experience required.

  • Must have experience working within a regulated industry.

  • Previous auditing experience required.

  • CAPA and root cause analysis experience required.

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.

Primary Work LocationUSA NE - Broken Bow

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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