QA Inspector

Canon Medical Diagnostics USA Inc•Mountain View, CA

3h•$20 - $23•Onsite

About The Position

The QA Inspector position is located in Mountain View, CA. This position will be responsible for using standard operating procedures and good manufacturing practices; conducting analysis of incoming raw materials, in-process materials, and finished products. The QA Inspector will receive general instructions for routine work and new assignments.

Requirements

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 apply logic for data analysis and manage projects from beginning to end within established timeline.
Ability to communicate in English (verbal and written).
Effective problem-solving and decision-making skills.
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.) and micro-centrifuges
Ability to understand and translate basic blueprint dimensions
Working knowledge of clinical analyzers (Luminometers preferred).
Ability to analyze and troubleshoot problems.
Demonstrate a positive and professional demeanor throughout all departments
Self-motivated and self-initiating

Nice To Haves

Basic understanding of 21CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive
Working knowledge of handling bio-hazardous materials
Knowledge of risk analysis/FMEA
AA Sciences/Engineering or equivalent
Experience in a medical device or pharmaceutical company.
Experience in an FDA/ISO regulated industry

Responsibilities

Follow detailed Quality Assurance inspection procedures
Perform metric inspections of raw materials, finished goods and packaged goods
Identify non-conforming materials and protocol / procedural errors, deviations, Out of Trend/Out of Specification events
Evaluate analytical results and determine conformance to specification
Document test results, problems and other relevant information
Maintain laboratory equipment to assure accuracy and confidence in performance
Train new personnel in QA procedures
Tracking and trending on product components and finished goods
Regularly cleans and maintains a neat/ organized work area
Participate in continuous improvement activities
Participate in the development, implementation and maintenance of Quality Systems/ other Quality Assurance activities
Perform customer complaint testing
Maintain laboratory inventory and orders supplies, as needed
Perform initial troubleshooting of issues which arise during routine analysis
Other duties as assigned