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Quality Assurance Engineer

Milwaukee, Wisconsin

Post Date: 07/17/2017 Job ID: 9366 Category: Technology

 

Job Description

The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles.

 
  • Drive continuous improvement actions focused on product quality.
  • Works with Engineering and Manufacturing to develop acceptance criteria for production processes.
  • Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions.
  • Analyzes production quality data to identify trends or issues which require action or CAPA activity.
  • Assists in creating and implementing procedures in the quality management system.
  • Assists in the review and disposition of nonconforming materials.
  • Assists in the creation and validation of manufacturing processes.
  • Conducts internal audits of production processes and report results.
  • Reviews manufacturing process and part deviations.
  • Creates quality alerts when acceptance activities need to be adjusted.
  • Supports external regulator or customer audits
  • Provides response to inquiries related to quality assurance arising from tenders or other sales efforts.
  • Performs other duties as requested.

 

Qualifications:
  • Bachelor of Science degree in Engineering or related field.
  • 3+ years relevant work experience.
  • Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
  • Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc.
  • Understanding of statistical analysis techniques and tools.
  • Experience with formal quality systems such as ISO 13485 or ISO 9001.
  • ASQ or related quality certification is preferred.
  • Work experience in a FDA regulated environment is preferred.
  • Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
  • Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
  • Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems.
  • Excellent verbal and written communication skills using the English language.
  • Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
  • Detail oriented with good organizational and record keeping skills.
  • Ability to work independently and as part of a team.
  • Proactive and timely in execution of assigned tasks.
  • Able to be flexible and adaptable when needs and priorities change        

 

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