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Quality Engineer at FUJIFILM Holdings America Corporation

Quality Engineer

FUJIFILM Holdings America Corporation Madison, WI (Onsite) Full-Time

We are recruiting for the new role of Quality Engineer to support our continued growth and on-going development projects.  Qualified individuals need have the capability, and to be inspired to support both the development of therapeutics (cGMP) and life science (non-cGMP) products and tools to support research endeavors.  We aspire to improve the quality of life through our efforts.  In return we provide development and support to enhance your career using cutting edge iPSC technology.
In this highly critical and visible role you'll support quality assurance initiatives, ensuring implementation of quality systems and compliance with applicable regulations, guidelines, and quality standards.  You will also provide support to cross functional teams for development and manufacture of products, and perform functional responsibilities to include but not limited to supplier management, external audits, root cause analysis, change management, material and method qualifications, and risk management.  If you aspire to be a critical resource in creating and maintaining a culture of quality, compliance, and cost initiatives, we offer an exceptional and unique opportunity to fully develop your career potential.
FUJIFILM Cellular Dynamics, Inc. (FCDI) is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living.

External US

Provide quality assurance expertise and guidance for new product development, technology transfer, manufacturing operations, supplier development, and product quality
Execute supplier management activities including but not limited to supplier qualification, audits, complaints, and supplier change notifications.
Support investigations, root cause analysis and risk management by making data driven and technical decisions, using critical thinking skills.
Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards associated with product manufacture and release.
Write, revise, review and approve standard operating procedures.
Participate in regulatory inspections and/or external client audits.
Other job functions as assigned.
Required Skills/Education:
Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology
3 years of relevant quality assurance experience, with demonstrated achievements and progressive responsibilities.
Demonstrated proficiency in performing audits
Demonstrated proficiency with statistical analyses such as Design of Experiments and Trending Analysis.
Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders.
Demonstrated ability to work concurrently in regulated and non-regulated environment.
Proficiency with MS office suite of products
Functional proficiency with an eQMS solution
Ability to travel overnight to include 15% travel annually
Able to work at computer for extended periods of time
Desired Skills:
Certified Quality Engineer

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

If COVID-19 vaccine is mandated by the federal government, or by state or local government, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.  For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

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