Quality Assurance Specialist

San Jose, CA

Full-Time

1 st 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.