Quality Engineer

Requirements

• BS/MS/PhD in Science or Engineering
• Post-graduate, certification, and/or license may be required.
• Minimum 4 years working in a Quality Management role in a regulated industry and experience interfacing with regulatory bodies
• Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR.
• Quality Experience in Medical Device Manufacturing
• FDA, and EU regulated work experiences desired
• Fluency with Six Sigma and/or Lean Manufacturing desired
• Problem solver, root cause analysis methodology
• Essential Skills
• Solid understanding of quality systems and regulatory compliance
• Strong attention to detail and documentation accuracy
• Problem‑solving and analytical thinking skills
• Ability to work independently within defined processes
• Effective communication and cross‑functional collaboration
• Ability to mentor junior team members
• Additional Details
• This job has a full time weekly schedule. Applications for this job will be accepted until at least June 30, 2026 or until the job is no longer posted.

Benefits

Additional Information

Job Description The Manufacturing Quality Engineer, Representative is responsible for executing and managing core quality assurance activities to ensure product quality and adherence to the Quality Management System (QMS). This role operates with increasing independence and technical proficiency, contributing to investigations, CAPA, audits, validation support, and process improvements. The position also begins to provide guidance to less experienced staff and supports maintaining inspection readiness across manufacturing operations. Essential Duties & Responsibilities Quality Systems & Compliance Execute and maintain Quality Management System (QMS) processes in alignment with Agilent standards and applicable regulatory requirements (e.g., FDA, ISO, cGMP) Ensure manufacturing processes, documentation, and activities comply with approved procedures and regulatory expectations Support and actively participate in maintaining site inspection readiness Documentation & Review Review and approve SOPs, batch records, and quality documentation within defined authority and training Perform batch record review, label issuance, and ensure documentation accuracy, completeness, and compliance Support document control processes and change implementation Product & Process Quality Perform product disposition activities for raw materials and finished products within assigned scope Support product logistics, retain inspection, and quality monitoring processes Ensure materials, equipment, and production processes meet established specifications Investigations, CAPA & Quality Records Initiate, review, and approve Non‑Conformances (NCRs) within defined scope Initiate, support, and approve CAPAs in compliance with quality system requirements Support investigation of product and process issues using structured problem‑solving tools Monitor and support closure of quality records to ensure timeliness and compliance Audits & Inspections Support internal, external, and regulatory audits and inspections Assist in audit preparation, execution, documentation, and follow‑up activities Provide documentation and information as required during inspections Validation, Equipment & Technical Support Review CAL and PM program records to ensure compliance Support equipment qualification and validation activities Review and approve QC investigations, test results, and rework activities within scope Metrics & Continuous Improvement Maintain site quality metrics and support trending activities Analyze basic trends and support identification of improvement opportunities Participate in quality improvement initiatives and project teams Collaboration, Training & Development Collaborate cross‑functionally with Manufacturing, Engineering, QC, and Supply Chain teams Serve as a qualified trainer for assigned processes and procedures Coach and mentor less experienced QA professionals Support site compliance programs, as applicable Demonstrate Agilent Values and Behaviors

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Company Intel

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