Quality Engineer

Quality Engineer at Pentangle Tech Services | P5 Group Quality Engineer at Pentangle Tech Services | P5 Group in Jacksonville Beach, Florida Posted in 3 days ago.

Type:

full-time

Job Description:

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.