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Job Information

J&J Family of Companies Specialist Quality Assurance in Redwood City, California

Auris is 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.

Overview:

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.

Core Job 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 non-conformance 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.

    Physical Demands

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

    Position Type and Expected Hours of Work

    This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-California-Redwood City-150 Shoreline Dr

Organization

Auris Health, Inc. (6267)

Job Function

Quality

Requisition ID

2105972466W

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