Quality Engineer- Life Sciences

Job Description

The Quality Engineer will be responsible for ensuring quality system compliance by driving the resolution of quality events.

Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. We offer 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. 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. Additional campuses are located across the US, Europe, China, and Japan, offering 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.”

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.

Required Skills/Education

• 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.

Pay And Benefits

For California, the base salary range for this position is $106,185.25- $125,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

EEO Information

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.

ADA Information

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 (flbi@fujifilm.com).