Quality Assurance Engineer

Position Overview

Position Description

Hours: 8:30am-5:00pm EST

We are seeking a driven Quality Assurance Engineer to join our team. In this pivotal role, you will lead quality system enhancements, address deviations, and tackle product nonconformities. You will play an essential part in implementing efficiencies, conducting risk assessments, and managing quality-related customer support while ensuring compliance with ISO 9001 standards. Your leadership will be crucial in maintaining the integrity of all Quality Assurance and Validation functions in alignment with ISO 9001 and relevant regulations.

Company Overview

At FUJIFILM Biosciences, our mission is to translate curiosity into meaningful advancements in life sciences. We offer an extensive range of products and services, including cell culture media, discovery research reagents, and essential assay materials. By collaborating with leading minds in biotech and pharma, we tackle major health challenges, contributing to innovative breakthroughs like vaccines and therapeutic advancements. Our culture thrives on curiosity, collaboration, and excellence, delivering top-tier quality and service to our partners. Join us at FUJIFILM Biosciences to make a significant impact in the world of life sciences.

Our headquarters in Santa Ana, California, offers a beautiful setting with access to renowned schools, picturesque parks, and stunning beaches. With campuses across the globe, including the US, Europe, China, and Japan, we provide opportunities to make a difference on an international scale.

Fujifilm is globally headquartered in Tokyo, employing over 70,000 individuals across diverse business segments, including healthcare and electronics. We operate under our core principle of "giving our world more smiles."

Job Responsibilities:

• Conduct and assist with incoming inspections, batch records, documentation, batch release, validation, and continuous improvement.
• Participate in the creation, revision, and training of critical documentation.
• Support internal, customer, supplier, and regulatory audits to ensure compliance.
• Review and approve raw materials, intermediates, and finished products.
• Lead and execute validation initiatives to maintain quality standards.
• Manage trend analysis, data reviews, and performance indicators while championing continuous improvement projects.
• Investigate and verify information surrounding non-conformances and drive corrective actions.
• Serve as a liaison for customer inquiries, ensuring a customer-centric approach to quality.
• Coordinate customer surveys and audits, bolstering quality assurance through feedback.
• Assist in supplier qualifications and change notifications while ensuring effective supplier management.
• Perform additional duties as assigned to support overall quality efforts.

Required Skills/Education:

• Bachelor's degree in a relevant field such as Science, Engineering, or Technology.
• At least 5 years of experience in Quality Assurance.
• Thorough understanding of ISO 9001 and GMP standards.
• Proficient in tissue culture, biochemical, and microbiological testing methodologies.
• Strong analytical skills to assess information and communicate findings effectively.
• Demonstrated ability in process improvement, standard development, and quality engineering.
• Effective verbal and written communication skills in English.

Benefits:

• Medical, Dental, Vision coverage
• Life Insurance
• 401k plan
• Paid Time Off