A technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. The Quality Assurance Specialist is responsible to provide general quality assurance support in the areas of inspection, document control and the overall maintenance of the quality management system. This position... more details
Quality Assurance Specialist San Jose, CA Full-Time 1st Shift Contract until 12/31/2024 Compensation: $30-34/hr
Kelly Science and Clinical is hiring a Quality Assurance Specialist for a temporary opportunity with one of our global medical device & biotechnology clients to work in San Jose, CA This is a great way to gain industry name experience and grow your science and biotechnology career! Work directly with ground-breaking medical devices helping save lives day after day.
SUMMARY A technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. The Quality Assurance Specialist is responsible to provide general quality assurance support in the areas of inspection, document control and the overall maintenance of the quality management system. This position supports both R&D and Operations through all phases of product lifecycle. The candidate will utilize SAP to document Quality transactions as well as assist in compiling and trending quality data.
RESPONSIBILITIES
Performs Quality review of documents related to QC testing, receiving inspection and lot history records (LHR) or device history record (DHR) as required.
Verifying product meets specifications and provide final quality approval.
Initiate and process Non-Conforming Material Reports when required and documenting nonconformance to specifications through the completion of required paperwork, SAP system transactions.
Handling sub-assemblies, final assemblies per the documented disposition and document activities in the appropriate systems.
Understanding of QSR/ISO 13485, 21 CFR 820, GMP environment and document results per GDP standards.
Supporting and participating in internal and external audits such as Notified Body and FDA as needed.
Performs incoming and in-process inspection of products as needed.
Assists in developing and implementing effective inspection to verify compliance of product with specifications.
Assists in developing inspection requirements and sampling plans for components and performs inspection activities as required.
Perform inspections of purchased parts, subassemblies, or finished company products according to specifications or standards using standard physical, mechanical and/ or electrical measurements as needed.
Accurately document the results of the inspections and testing in SAP and on data sheets/forms as applicable.
Maintaining all controlled document files and test records in a timely and accurate manner.
Participate and/or assist in writing and updating inspection procedures, protocol, and checklists
QUALIFICATIONS
Minimum HS diploma and practical experience. AA or AS degree preferred.
3+ years Quality Assurance and Quality Control experience preferred.
Working knowledge of the FDA medical device Quality Systems Regulations and international quality system standards QSR/ISO 13485 and 21 CFR 820.
Ability to read and comprehend engineering drawings and schematics is preferred.
Ability to work independently, prioritize activities and communicate well.
Proficient in analytical, written, oral communication skills; and the ability to manage a variety of tasks simultaneously within cross-functional teams under minimal day-to-day supervision.
Proficient technical writing skills and use of documentation programs (e.g., Office Windows, Excel, Access, Power Point, etc.).
Able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, working individually and with others within and outside the quality function.
Previous experience with SAP preferred.
Proficient in knowledge of a variety of testing equipment (including Instron, pin gages, snap gages, micrometer, caliper, etc.) is helpful.
Work Environment: This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
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Send resumes to Jacqueline.Sayoc@KellyScientific.com
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