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Quality Engineer II/III Incoming Inspection

Localisation: Salt Lake City, UT, États-Unis
Type de Contrat: Unfixed Term
Fonction: Manufacturing

Description

Primary Duties

  • Perform all work in compliance with the company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System
  • Lead the NCR, CAPA, validation and risk management systems to ensure the following:
  • Relevant procedures and requirements are considered and applied
  • Timely completion of activities
  • Lead and guide teams with investigation methodologies and validation strategies
  • Document notes, action item recording and follow through, and communication to senior leaders as needed
  • Manage large and/or complex projects when assigned
  • Work with Engineering to define metrology tools
  • Design and implement measurement systems for incoming materials QA inspection team of raw materials used in production
  • Read, understand and interpret equipment specifications, test procedures, etc. and be able to write procedures that outline the calibration and maintenance of Measurement & Test Equipment.
  • Lead teams with investigation methodologies and provide guidance on validation strategies for measurement systems
  • Define, document, and create work instruction procedures and technical reports utilizing GD&T methodologies
  • Define, document, and analyze Gauge R&R studies
  • Train and mentor incoming materials inspection team on metrology and measurement systems

Training and Education

  • Required – Bachelor’s Degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.
  • Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
  • Mechanical Engineering degree preferred but not required

    Experience
  • 5+ year of experience in Engineering, Scientific or Investigative role is required.
  • Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is required.
  • Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) required.


Knowledge, Skills, and Abilities

  • Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
  • Technical writing skills
  • Ability to collaborate cross-functionally
  • Application of Quality Risk Management principles
  • Attention to detail (e.g. document reviews, investigation write ups).
  • High level of written and verbal communications skills
  • Ability to communicate with Statisticians and perform statistical calculations as instructed.
  • Wisdom to seek help when needed.
  • Proficiency in MS Office tools, including Outlook, Word, and Excel
  • Development of trends and measurement charts
  • Advanced project management/leadership skills
  • Creating and giving training presentations
  • Mentoring peers and leading groups
  • SPC methodologies
  • Defining, designing, and writing procedures
  • Knowledge and experience with parts drawing interpretation and tool application
  • Flowcharting of procedures and processes
  • Creating and giving training presentations
  • Intermediate to professional level technical writing skills
  • Advanced Microsoft application skills (i.e Excel, Word, PowerPoint, Visio)
  • Statistical software experience, e.g MiniTab, JMP, R Script, preferred
  • Effective verbal and written communication skills
  • Ability to effectively present information and respond to questions
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Working Conditions and Physical Requirements
  • Ability to remain in stationary position, often standing, for prolonged periods.
  • Ability to ascend/descend stairs, ladders, ramps, and the like.
  • Ability to operate heavy machinery.
  • Ability to adjust or move objects up to 50 pounds in all directions.
  • Potential for domestic travel for training
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