QA Engineer — ISO 9001, Validation & CAPA Lead

FUJIFILM Healthcare Americas Corporation; Warminster Township (Bucks County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences is hiring a Quality Assurance Engineer in the United States (Warminster Township area). The role centers on improving the Quality System, driving deviations and nonconformances to resolution, and ensuring ISO 9001 compliance across QA & Validation functions.

Responsibilities include inspections, batch release, validation activities, audits, data reviews, and customer liaison. Requires a bachelor’s in science/engineering and 5+ years in QA with strong English communication.

Qualifications

• Bachelor’s degree in Science, Engineering, Technology, or a related field.
• Minimum of 5 years of experience in Quality Assurance.
• Strong understanding of ISO 9001 and GMP requirements.
• Experience in batch records, raw materials, intermediates, and final products review and release.
• Experience in leading and executing equipment and process validation activities; investigations, customer surveys, audits.
• Ability to speak, write, and read English well.
• Good oral and written communication skills.

Responsibilities

• Perform and assist with incoming inspection, batch records, documentation, training, batch release, validation, deviation, complaint, investigation, continuous improvement, and system reviews.
• Assist with document creation, revision, issuance, and training.
• Support internal, customer, supplier, and regulatory audits.
• Review and release raw materials, intermediates, and final products.
• Lead and execute validation activities.
• Manage trend reviews, data reviews, KPI management, and continuous improvement projects.
• Assess, investigate, and verify information related to non-conformances.
• Drive continuous improvement within the organization, particularly concerning non-conformance CAPA, audit observations, complaints, and other quality datasets.
• Act as customer liaison for internal inquiries and provide the voice of the customer.
• Coordinate and complete customer surveys, questionnaires, and audits.
• Support supplier questionnaires and qualifications.
• Support change notifications and supplier management.
• Other duties as assigned.

Skills

Quality Assurance

ISO 9001

GMP

Documentation

Education

Bachelor's degree in Science/Engineering/Tech

Job description

FUJIFILM Biosciences is hiring a Quality Assurance Engineer in the United States (Warminster Township area). The role centers on improving the Quality System, driving deviations and nonconformances to resolution, and ensuring ISO 9001 compliance across QA & Validation functions.

Responsibilities include inspections, batch release, validation activities, audits, data reviews, and customer liaison. Requires a bachelor’s in science/engineering and 5+ years in QA with strong English communication.