Quality Engineer (Jacksonville)
4 days ago
Jacksonville
Job Description: Key Responsibilities • Aid in development and execution of qualification documentation, including IQ, OQ, and PQ protocols for lidstock and heat-seal processes., • Lead and support the implementation, qualification, and validation of new raw materials for the production lines under the direct supervision of J&J stakeholders., • Review and maintain controlled documentation (e.g., quality procedures, test methods, and specifications) in support of process and product validation., • Support process characterization and qualifications by assisting in preparing and executing protocols, test suites, and supporting documentation., • Manage and support change control activities for lidstock and heat-seal processes, ensuring appropriate risk assessment and documentation updates., • As needed, perform and document risk assessments and provide technical input to investigations, deviations, CAPAs, nonconformances, and qualification activities; support root cause analysis for manufacturing equipment, processes, and systems., • Ensure adherence to the Quality Management System (QMS), maintaining compliance with FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory and internal requirements., • Provide support for issue resolution, including investigations, bounding/containment, action tracking, and review/approval of nonconformances, CAPAs, and audit responses. Responsibilities:\ • The Quality Validation Engineer will lead and support validation and qualification activities for lidstock and heat-seal processes and related raw materials, ensuring compliant execution of IQ/OQ/PQ documentation, robust change control, and alignment with the Quality Management System (QMS)., • Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for lidstock and heat-seal processes, ensuring traceability to requirements and acceptance criteria., • Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines under the direct supervision of J&J stakeholders., • Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions., • Manage and support change control activities (change requests/records), including impact assessment, risk assessment (e.g., FMEA), implementation actions, and required documentation updates., • Review, maintain, and improve controlled documents (quality procedures, test methods, and specifications) in support of process and product validation., • Ensure qualification/validation packages are complete and compliant, including executed protocols, deviation documentation, investigations, final reports, and approvals per the QMS., • Provide technical input to investigations, deviations, nonconformances, and CAPAs, including containment/bounding, root cause analysis, action effectiveness, and timely closure., • Ensure day-to-day activities align with applicable requirements (FDA 21 CFR 820, ISO 13485, GxP) and support internal/external audits through documentation readiness and response support. Required Experience: • Hands-on experience supporting validation deliverables and technical documentation (DOE, IQ/OQ/PQ protocols and reports)., • Experience submitting test documentation and managing change requests/change control in a regulated quality system., • Experience conducting nonconformance investigations, root-cause analysis, and CAPA support., • Experience in a regulated industry (medical device preferred) with familiarity with FDA expectations., • Working knowledge of statistics and Design of Experiments (DOE), including basic data analysis and interpretation., • Six Sigma certification (Green Belt/Black Belt) is a plus., • Strong analytical skills, including risk assessment and attention to detail in technical documentation., • Ability to work independently, communicate effectively with stakeholders, and manage priorities; project management experience is preferred., • Proven ability to work in a cross-functional matrix environment, build strong relationships, and serve as a subject matter expert when needed., • Flexible and able to manage multiple priorities; willing to adjust schedule as required by business needs. Required Qualifications : Bachelor’s in engineering Primary focus areas: Materials, Mechanical, Industrial, Chemical Engineering or Equivalent Minimum 2-5 years of significant engineering and/or operational experience is required. Experience with successfully performing IQ/OQ/PQ Qualifications and Change Request Management highly preferred. *