Quality Systems Specialist
Analyze and trend all types of data (CAPA, problem records, complaints, on-market surveillance) to identify deficient areas and initiate quality improvement projects. Coordination and execution of Global Field Safety Notice/Customer Communications/Recalls including documentation of effectiveness. Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve. Identify, compile and refine metrics for quality and operation reports. Participate in and support internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness.
3-5 years of experience supporting a Quality Management system in a regulated industry
Ability to work independently as an individual contributor
Experienced with Quality tools, methodologies, and complaint investigations
Excellent understanding of regulations and standards such as; 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations
Project Management
Time Management
MS Excel
MS Word
MS Visio
Root-Cause Analysis
Process Improvement
Communication Skills
Adaptability
Detail Oriented and Organized
Multi-tasker
According to JobzMall, the average salary range for a Quality Systems Specialist in 5823 Newton Dr, Carlsbad, CA 92008, USA is $62,000 to $87,000 per year. This range can vary depending on a variety of factors, such as the type of industry, the size of the company, the specific job duties and responsibilities, and the level of experience and expertise of the individual.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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