QA Specialist III Job Mountain View area,California USA,Quality Assurance

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:

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.

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,…