Quality Engineer at Fujifilm

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 youll 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.

Responsibilities:

1. Provide quality assurance expertise and guidance for new product development, technology transfer, manufacturing operations, supplier development, and product quality

2. Work within, and occasionally leads, investigation project teams.

3. Support root cause analysis and risk management by making data driven and technical decisions, using critical thinking skills.

4. Execute supplier management activities including but not limited to supplier qualification, audits, complaints, and supplier change notifications.

5. Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards associated with product manufacture and release.

6. Write, revise, review and approve standard operating procedures.

7. Participate in regulatory inspections and/or external client audits.

8. 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

• Five 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 5-10% travel annually

• Able to work at computer for extended periods of time

Desired Skills:

• Certified Quality Engineer

EEO/COVID/AGENCY NOTES

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.