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Associate Manager, Quality Systems Compliance

Apply Now Job ID R-346887 Date posted 08/30/2019

Job Description Summary

The Associate Manager, Quality Systems Compliance will manage the Quality activities and personnel for multiple departments. Coordinate efforts for Corrective and Preventive Action, Non-Conforming Material investigations, and Internal/External Audits. Assure compliance to regulations, standards, and internal procedures. Support Continuous Improvement activities for quality systems. Provide regular updates to management of trends from these areas and oversee training/development activities for quality personnel.

Job Description

RESPONSIBILITIES

  • Manage quality activities and compliance programs including oversight for CAPA, MRR, Temporary Deviation, and Internal Audits. 
  • Ensure compliance to local procedures, regulations and standards for Medical Devices and Pharmaceutical products.
  • Responsible for identifying trends and coordinating presentations for Management Review and Platform meetings for area(s) of responsibility.
  • Directly supervise Quality Personnel as assigned.
  • Assist Quality Manager to support external audits (FDA, ISO, Segment Audits, Customer Audits, etc.)
  • Train / mentor Quality Engineers and other Quality personnel in plant
  • Assist Quality Engineers, Production Managers, Engineers and Supervisors on identification of root cause of quality problems or customer complaints.
  • Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
  • Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

REQUIREMENTS

  • BS degree in engineering or scientific discipline.
  • 6 years of experience in quality or manufacturing 
  • 1 year of direct supervisory experience of technical and/or degreed professionals. 
  • Leadership experience, Project management and advanced communication skills required. 

ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS

  • Medical device or pharmaceutical experience preferred. 
  • ASQ certified quality technician (CTQ), ASQ QE certification, and certified quality auditor (CQA) or auditing experience preferred. 
  • Experience with analytical problem solving skills, technical writing skills, Automated documentation systems and Root cause analysis preferred. 
  • Continuous Improvement experience and Six Sigma Green Belt certification/training is a plus. 
  • Process validation, Design of Experiment (DOE), 21 CFR 820-21/211 cGMP, ISO 13485-13485 experience preferred. 
  • Experience with Minitab, SAP, and Trackwise 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.

#LI-OPS

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift

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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