Quality Engineer- Life Sciences

Fujifilm•Santa Ana, CA

1d•$106,185 - $125,000•Onsite

About The Position

We are hiring a Quality Engineer. The Quality Engineer will be responsible for ensuring quality system compliance by driving the resolution of quality events. At FUJIFILM Biosciences, 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 Biosciences. 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

Requirements

A minimum of a Bachelor's degree or equivalent in an Engineering discipline.
A minimum of five (5) years of relevant work experience.
Knowledge of ISO standards and FDA guidelines/rules/regulations for medical device / pharmaceuticals.
Experience with deviation and nonconformance investigations, root cause analysis, CAPA, SCAR, and change control.
Ability to speak, read, and write English proficiently.
Proficient oral and written communication skills.

Responsibilities

Lead quality event investigations (e.g., NONC and DEV) and ensure timely resolution.
Lead cross-functional meetings and present investigation outcomes, quality risks, and recommendations to management.
Perform investigations (6M, 5WHY, RCA), risk assessments, and verifications of effectiveness.
Compile and analyze data utilizing statistical tools and techniques for quality events and process monitoring.
Generate and revise documents (e.g., SOPs).
Support audits, corrective and preventative action (CAPA) investigations, and process improvement initiatives.
Collaborate effectively with cross-functional teams to achieve KPIs and objectives.
May be required to perform other duties as needed.