Position Description

We are hiring a Lead, Quality Engineer. The Lead, Quality Engineer will oversee and lead multiple areas of the Quality System.

At FUJIFILM Irvine Scientific, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Responsibilities

• This role will lead MOC, NONC, DEV, and SCAR activities and meetings in accordance with industry standards, regulations, and internal requirements.
• Review, assess, and update Quality System processes to ensure compliance with pertinent requirements.
• Lead and support the tracking of departmental goals / KPIs.
• Compile and analyze data utilizing statistical tools and techniques for metric development and continuous improvement.
• Perform investigations (6M, 5WHY, RCA), risk assessments, and verifications of effectiveness.
• Lead kaizen events/projects for KPI and Quality Culture improvement.
• Generate, revise, and review document changes (e.g., SOPs).
• Provide responses for audit observations (internal, regulatory, customer).
• Provide training and guidance to all personnel in navigating/conducting Quality System processes.
• Provide guidance to the Quality Engineering team and oversee their activities.
• May be required to perform other duties as needed.

Required Skills/Education

• A minimum of a Bachelor's degree or University equivalent is required with a concentration in Engineering or related scientific field preferred.
• A minimum of six (6) years of relevant work experience.
• Experience leading and owning Quality System processes.
• Critical thinking skills, excellent written and verbal communication skills with attention to detail.
• Knowledge of ISO standards and FDA guidelines for medical device/pharmaceuticals.
• Advanced knowledge of Quality System processes (e.g., Change Control).
• Advanced knowledge of statistical tools and techniques (e.g., ANOVA and Minitab).
• Ability to speak, read, and write English proficiently.
• Proficient oral and written communication skills.

Salary and Benefits:

• For California, the base hourly range for this position is $103,093 - $134,204. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).