QA Engineer -ISO 9001 and GMP

Fujifilm - Warminster, PA

Full-time - Mid Level

Warminster, PA

Machinery Manufacturing

About the position

The Quality Assurance Engineer at FUJIFILM Irvine Scientific, Inc. plays a pivotal role in enhancing the Quality System and ensuring compliance with ISO 9001 and GMP requirements. This position is integral to the organization, focusing on the resolution of deviations and product nonconformance while driving continuous improvement initiatives. The engineer will be responsible for overseeing all Quality Assurance and Validation functions, ensuring that the highest quality standards are maintained throughout the manufacturing process. This includes performing and assisting with incoming inspections, batch records, documentation, training, batch release, validation, and investigations related to deviations and complaints. In this role, the Quality Assurance Engineer will also manage quality-related customer support, acting as a liaison for internal inquiries and providing the voice of the customer. The engineer will coordinate and complete customer surveys, questionnaires, and audits, as well as support supplier qualifications and change notifications. The position requires a proactive approach to identifying and implementing efficiencies, leading risk assessments, and managing trend reviews, data reviews, and KPI management. The engineer will be expected to drive continuous improvement within the organization, particularly concerning non-conformance, CAPA (Corrective and Preventive Actions), audit observations, and other quality datasets. The ideal candidate will possess a strong understanding of quality assurance principles and practices, with a focus on detail and a commitment to quality and continuous improvement. This role is essential for maintaining the integrity of the company's products and services, ensuring that they meet the rigorous standards expected in the biopharmaceutical and medical device industries.

Responsibilities

• Lead Quality System improvements and drive resolution of deviations and product nonconformance.
• 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.

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.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Detail-oriented with a strong focus on quality and continuous improvement.

Nice-to-haves

• Statistical Analysis
• Process Improvement
• Project Management