BD (Becton, Dickinson and Company) Quality Assurance Manager in El Paso, Texas

Job Description Summary

Job Description

Summary

The Quality Assurance Manager is responsible for strategic oversight and leadership direction within the Production QA function to include: In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures.

Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.

Duties and Responsibilities

  • Effective implementation of the site QMS

  • Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology

  • Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)

  • Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.)

  • Responsible for Production and Process Controls from a Quality perspective

  • Serves as a technical resource for all QA activities

  • Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue

  • Advises others on a variety of topics within own functional area

  • Tracks internal trends and suggests process improvements based on observations

  • Leverages the appropriate resources to provide solutions for internal/external customers

  • Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns

  • Identifies implications/conclusions from the logical analysis of a complex situation or issue

  • Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits

  • Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success

  • Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department

Qualifications

  • Bachelor of Science degree in an engineering or related field.

  • Minimum 7 years' experience in quality, with at least 3-5 years in the medical device industry

  • Minimum 2-3 year's management experience

  • Experience in interface with Domestic and Foreign government agencies

  • Experience with SAP preferred

  • Experience in Lean/Six Sigma preferred

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

Physical Demands

  • Must be able to lift, push/pull, and carry up to 25 pounds

  • Must be able to wear appropriate personal protective equipment as required

  • Position requires sitting or standing for long hours

  • Use of hands and fingers to manipulate office and calibration equipment is required

#LI-OPS

Primary Work LocationUSA TX - El Paso

Additional Locations

Work Shift