QA Specialist III

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.

Essential Duties and 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

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

• 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
• Knowledge of risk analysis/FMEA (preferred)
• 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

Education and Experience:

• AA Sciences/Engineering or equivalent desired.
• Minimum of 4-years’ experience working in a medical device or pharmaceutical company.
• Experience in an FDA/ISO regulated industry preferred.

Supervisory Responsibility:

This position has no supervisory responsibilities.

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, lab 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 3 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

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

• 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

Wage Range:

$24.00 - $29.00/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

Travel Demands:

N/A

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

Canon Medical Diagnostics USA, Inc. (CMDU) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, genetics or any other legally protected class period 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.