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Jobs at Canon Medical Diagnostics USA, Inc. (Now Hiring) — 1 open

Canon Medical Diagnostics USA, Inc.

QA Inspector

Mountain View, California, United States · On-site

$20/hr–$23/hr

Entry level

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-pro…

Skills: Quality Assurance Inspection, Metric Inspections, Data Analysis, GLP/GDP, Microsoft Office

QA Inspector

Canon Medical Diagnostics USA, Inc.

Mountain View, California, United States • On-site

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Entry level

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  • $20/hr–$23/hr
  • Full-time
  • associate degree
  • 401k With Company Match, Fsa, Hsa, Medical Insurance, Dental Insurance, Vision Insurance
  • Posted 36d ago
  • ~40 hrs/week

Responsibilities

Responsible for conducting quality assurance inspections of raw materials, in-process materials, and finished products using standard operating procedures. Duties include documenting test results, maintaining laboratory equipment, and participating in continuous improvement activities.

Requirements

Requires an associate degree in sciences or engineering and experience in a medical device or pharmaceutical environment. Candidates should be proficient in GLP/GDP, metrology instruments, and regulatory standards like ISO 13485.

Full job description

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. 

Essential Duties and Responsibilities:

  • 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

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position):

  • Basic understanding of 21CFR 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 VisioStrong 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.
  • Demonstrate a positive and professional demeanor throughout all departments
  • Self-motivated and self-initiating

Education and Experience:

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

Supervisory Responsibility:

  • N/A

Work Environment:

  • 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

Physical Demands:

  • 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

 Position type and expected hours of work: 

  • Full-Time 

Travel Demands: 

  • N/A

 Wage Range:

  • $20.00 - $23.00/hour

Benefit Options:

  • 401K w/ Company Match 
  • FSA and HSA 
  • Medical, Dental, Vision 
  • Life/AD&D
  • Short Term Disability & Long Term Disability
  • Pet Insurance 
  • Aflac
  • Paid Vacation & Holidays

 Affirmative action plan/equal employer opportunity (AAP/EEO) statement:

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.

Disclaimer

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.

Related keywords

QA InspectorMedical DevicePharmaceuticalFDAISO 1348521CFR 820MHLW Ministerial Ordinance 169IVD DirectiveGLPGDPAX DynamicsCalipersHeight GaugesPin GaugesMicrometerMicro-centrifuges

About Canon Medical Diagnostics USA, Inc.

LinkedInVisit site

Canon Medical Diagnostics USA manufactures the OPTIGEN® Allergy Test, in Mountain View, CA.

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Headquarters
Mountain View, California
LinkedIn followers
536

Canon Medical Diagnostics USA helps the medical community provide quality allergy care in a timely and affordable manner. The OPTIGEN® Allergen-Specific IgE Assay Test is a comprehensive panel test for environmental and food allergens.

Offices: 630 Clyde Ct, Mountain View, California 94043, US

In Vitro Allergy TestingBiotechnology DevelopmentInnovationAllergyAsthmaImmunologyBiotechAllergensand Medical
View all jobs at Canon Medical Diagnostics USA, Inc.

About Canon Medical Diagnostics USA, Inc.

LinkedInVisit site

Canon Medical Diagnostics USA manufactures the OPTIGEN® Allergy Test, in Mountain View, CA.

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Headquarters
Mountain View, California
LinkedIn followers
536

Canon Medical Diagnostics USA helps the medical community provide quality allergy care in a timely and affordable manner. The OPTIGEN® Allergen-Specific IgE Assay Test is a comprehensive panel test for environmental and food allergens.

Offices: 630 Clyde Ct, Mountain View, California 94043, US

In Vitro Allergy TestingBiotechnology DevelopmentInnovationAllergyAsthmaImmunologyBiotechAllergensand Medical
View all jobs at Canon Medical Diagnostics USA, Inc.

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