Quality Engineer

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.