QA Inspector

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.

• Follow detailed Quality Assurance inspection procedures
• Perform metric inspections of raw materials, finished products 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

• Basic understanding of 21
  
  CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive (preferred)
• 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.
• Working knowledge of handling bio-hazardous materials (preferred)
• 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
• Knowledge of risk analysis/FMEA (preferred)
• Working knowledge of clinical analyzers (Luminometers preferred).
• Ability to analyze and troubleshoot problems.
• Demonstratea positive and professional demeanor throughout all departments
• Self-motivated and self-initiating

• AA Sciences/Engineering or equivalent (preferred)
• Experience in a medical device or pharmaceutical company.(preferred)
• Experience in an FDA/ISO regulated industry (preferred)

• N/A
• Laboratory Environment
• Exposure to blood-borne pathogens and hazardous chemicals
• Exposure to a cold room (2-8°C) environment for up to 30 minutes continuously at a time
• Must wear protective equipment such as safety glasses, laboratory coats, hairnets, face shields and any relevant equipment deemed as necessary

• Ability to lift up to 30 pounds (totes/containers)
• Ability to work in a cold room (2-8°C) environment for up to 30 minutes continuously at a time
• Prolonged viewing of computer screen
• Frequent use of mouse and keyboard for up to 2 hours at a time and up to 8 hours daily
• Ability to sit or stand, up to 2 hours continuously at a time and up to 8 hours or more in a day
• Specific vision abilities include close vision, and the ability to adjust focus

• Full-Time

• N/A

• $20.00 - $23.00/hour

• 401K w/ Company Match
• FSA and HSA
• Life/AD&DD
• Short Term Disability & Long Term Disability
• Pet Insurance
• Aflac
• Paid Vacation & Holidays

Canon Medical Diagnostics USA. (CMDU) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, CMDU complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. CMDU management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.