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Quality Control Analyst

Company: CoaguSense
Location: Fremont
Posted on: September 23, 2022

Job Description:

SUMMARY The Quality Control Analyst will perform, document and analyze routine testing of consumable test strips and provide assistance to QC as needed to support the manufacture of in-vitro diagnostic/medical device products per internal procedures and specifications. This position also performs the inspection and testing of incoming raw materials and identifies nonconformities to QA. The position must have the necessary experience to assure compliance to applicable medical device state, federal, and international standards and laws, including QSRs, ISO 13485 and AAMI/ANSI. ESSENTIAL DUTIES AND RESPONSIBILITIES Testing of product samples in a QC laboratory setting per established procedures. Data input following testing with the appropriate analysis of acceptance. Completion of records with a high attention to detail and accuracy. Must have general laboratory skills and an understanding of Good Laboratory Practices either in QC or manufacturing. Routine testing includes preparation of control materials, pipetting of control solutions and ability to interpret results based on product requirements. Similar testing and/or sample preparations will be required to support stability studies and R&D activities as needed and requested. Complete appropriate testing and release documentation for batch records. Review data to ensure accuracy and regulatory compliance. Interpret test results, compare them to established specifications and control limits. Investigate or report questionable test results. Participate in out-of-specification and failure investigations. Individual will perform routine incoming inspection of raw materials and components used in manufacturing, according to established Material Specifications. Responsibilities include identifying, documenting and managing nonconforming materials per internal procedures and in conjunction with Manufacturing, Procurement and QA. Must have experience with the use of inspection measurement tools. Responsible for the compilation of laboratory and/or inspection test data to perform appropriate analyses. Ensure that lab cleanliness and safety standards are maintained. QUALIFICATIONS Must have a working understanding and knowledge of Good Laboratory Practices and both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices - Quality Management Systems. Demonstrated ability to perform detail oriented work with a high degree of accuracy and recall. Requires strong written, oral, interpersonal, group, and communication skills. Effective organization and planning skills. Must be able to follow established policies and procedures and comply with regulatory requirements. Computer skills are required, with experience using Microsoft Word, Excel, and PowerPoint. Position works closely with project teams, manufacturing support personnel, and other departments within the company. Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above and below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE A minimum of 5 to 7 years of experience in the medical device and/or in-vitro diagnostics industries with direct experience in QC or other laboratory environment. Bachelor's degree in the life sciences or equivalent required with a demonstrated skillset in laboratory techniques and data analysis. LANGUAGE SKILLS The ability to communicate articulately, in English, both verbally and in written materials is required. MATHEMATICAL SKILLS The candidate must be able to perform basic math functions. Application of statistical methods and analyses is recommended. PI191986374

Keywords: CoaguSense, Fremont , Quality Control Analyst, Professions , Fremont, California

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