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Quality Assurance Specialist

2 months ago

Warminster Pennsylvania, United States Fujifilm Full time
About the Role

Fujifilm is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities
  • Lead Quality System improvements and drive resolution of deviations and product nonconformance.
  • Identify and implement efficiencies, lead risk assessments, manage quality-related customer support, and ensure compliance with ISO 9001 requirements.
  • Oversee and ensure that required quality exists in all Quality Assurance & Validation functions as prescribed by the ISO 9001 and GMP requirements.
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 Preventive 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.
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.