QA Engineer

Fujifilm • Northampton Township, PA

2d • Onsite

About The Position

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 Quality Assurance & Validation functions as prescribed by the ISO 9001 and applicable standards/regulations.

Requirements

• 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.

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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior