Fluidigm

  • QA Specialist III

    Job Locations US-CA-South San Francisco
    Req No.
    2018-2746
    Category
    Quality Assurance / Regulatory
    Type
    Regular
  • Job Description

    The right job isn’t about location or benefits or responsibilities. The right job is about personality, character, motivation, and fulfillment. It’s about what inspires us, what we’re passionate about.

     

    At Fluidigm, we’re passionate about life. Exploring it, studying it, sustaining it, living it. We make biotech tools that enable our customers and ourselves to seek truth in applied life sciences. To push limits and envision ever more creative answers to “what if…?”

     

    Naturally, we’re also passionate about people, especially the ones we work with. We know that the right people in the right positions can do amazing things, and we love helping that happen.

    Now we’re looking for a well-rounded and knowledgeable QA Specialist III to join our Quality Assurance team.

     

     

    Essential Duties and Responsibilities

    • Be responsible for overseeing the Risk Management program, including risk assessment in the product development process and complaint handling process.
    • Be responsible for overseeing the Change Control program, including changes to product and document control.
    • Participate in product development teams as the voice of QA.
    • Participate in corporate CAPA processes, including corrective and preventive action, nonconformance reporting, and customer complaint handling.
    • Participate in the audit program (internal/external) and assist in third-party (regulatory and customer) inspections and audits to ensure compliance and ongoing certification/registration.
    • Assist with the continual improvement of the Fluidigm Quality Management System at the SSF site and across other sites.
    • May be called upon to review batch records and disposition of product for reagent manufacturing in-process and finished goods.
    • Have fun, be fully engaged and promise to have a life beyond “work”.

    Required Education/Experience:

    • Technical Degree (BS or higher) in a biological or chemical science and 3-5 years of experience working within/developing Quality Systems in compliance with ISO, FDA and European regulations/standards; additional experience (5-10 plus years) may be accepted in lieu of a degree.
    • Prior experience managing/overseeing risk management (ISO 14971) and change control required.
    • Recent (within two years) hands-on auditing experience (internal, external, third-party).
    • The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced.
    • ISO 13485:2016 lead auditor certification a plus.
    • Exposure to reagents and instruments is a plus.
    • Experience with in vitro diagnostic medical device product preferred.

     

    If this sounds like you, we will:

    • Deliver superior compensation, benefits and opportunities for career growth.
    • Engage you in a dynamic and rewarding company culture.
    • Support you in your ongoing development and contribution both as an employee and a person.
    • Value your contribution and enlist your feedback.
    • Host excellent company-wide events multiple times a year.
    • Offer onsite yoga classes, massages, randomly free and good food, friendly greetings, gym equipment and, seriously, a lot more!

     

     

    Apply online now with your resume and a link to your portfolio or website.

     

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