QA Engineer - Onsite - Warminster, PA

FUJIFILM; Warminster Township (Bucks County); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Holdings America Corporation is looking for a Quality Assurance Engineer in Warminster Township. This individual will lead quality system improvements and ensure compliance with ISO 9001 standards. Key responsibilities include overseeing inspections, managing quality support, and driving continuous improvement initiatives.

The role requires a Bachelor's degree in a related field and at least 5 years of experience in Quality Assurance. Benefits include medical, dental, vision, life insurance, and a 401k plan.

Qualifications

• Minimum of 5 years of experience in Quality Assurance.
• Strong understanding of ISO 9001 and GMP requirements.
• Experience in leading and executing validation activities.

Responsibilities

• Perform incoming inspections, batch records, and validations.
• Lead and manage quality-related customer support.
• Drive continuous improvement within the organization.

Skills

Quality Assurance

ISO 9001

GMP requirements

Document management

Communication skills

Education

Bachelor’s degree in Science, Engineering, Technology

Job description

Position Overview

Position Description

Onsite Full Time Hours: 8:30am-5:00pm EST

We are hiring a Quality Assurance Engineer. The Quality Assurance Engineer will be responsible for lead quality system improvements as well as drive resolution of deviations and product nonconformance. The role involves identifying and implementing efficiencies, leading risk assessments, managing quality‑related customer support, and ensuring compliance with ISO 9001 requirements. They will also oversee and ensure that required quality exists in all QA & validation functions as prescribed by ISO 9001 and applicable standards/regulations.

Job Description

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 (corrective and Preventative Actions), 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.

Required Skills/Education:

• 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.
• Experience in leading and executing investigations, customer surveys, questionnaires, and audits.
• Ability to speak, write, and read English well.
• Good oral and written communication skills.

Benefits

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

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 ([e-mail]).