QA Specialist III

Canon Medical Diagnostics USA Inc•Mountain View, CA

5d•$24 - $29•Onsite

About The Position

The QA Specialist III is located in Mountain View, CA. The qualified candidate will primarily be responsible for conducting analysis of incoming raw materials, in-process materials, and finished products while following standard operating procedures and good manufacturing and lab practices. This position will make recommendations, lead process improvements and receive general instructions for routine work and new assignments.

Requirements

Basic understanding of 21 CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive
Ability to calculate using algebra, statistics, weights/measures and the metric system
Basic working knowledge of Microsoft Office (Outlook, Excel, Word) and Visio
Strong working knowledge of GLP/GDP
Ability to use micro-centrifuges
Ability to apply logic during data analysis
Ability to manage projects from beginning to end within established timeline
Ability to communicate in English (verbal and written)
Effective problem-solving and decision-making skills
Working knowledge of handling bio-hazardous materials
Ability to work independently and cohesively in a team environment
Ability to transact materials/product with an MRP system (AX Dynamics preferred)
Ability to use hand-held metrology instruments (calipers, height gauges, pin gauges, micrometer, etc.)
Ability to understand and translate basic blueprint dimensions
Working knowledge of clinical analyzers (Luminometers preferred).
Ability to analyze and troubleshoot problems.
Ability to perform functional assays
Self-motivated and proactive
Demonstrate a positive and professional demeanor

Nice To Haves

Knowledge of risk analysis/FMEA (preferred)
Experience in an FDA/ISO regulated industry preferred.

Responsibilities

Follow detailed Quality Assurance inspection procedures
Perform metric inspections of raw materials
Identify non-conforming materials and protocol/procedure errors
Perform inspections of finished products and packaged goods
Evaluate analytical results and determine conformance to specification
Identify deviations and out of specifications events
Document test results, problems and other relevant information
Maintain laboratory equipment to assure accuracy and confidence in performance
Support QA Laboratory as needed
Train new personnel in QA procedures
Write Quality Assurance inspection protocols and validations
Perform inspection of Luminometers and associated equipment
Perform CLA Luminometer troubleshooting and repair
Regularly cleans and maintains a neat/ organized work area
Participates in continuous improvement activities
Participate in the development, implementation and maintenance of Quality Systems/ other Quality Assurance activities
Coordinates work assignments to meet production timelines
Performs customer complaint testing
Maintains laboratory inventory and orders supplies, as needed
Performs initial troubleshooting of issues which arise during routine analysis
Perform document changes and revisions