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Quality Assurance Manager - United States  

Company managed [?] Still accepting applications

Posted on : 12 August 2017

Project Description

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 Location

USA TX - El Paso

Additional Locations

Work Shift