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

Qualifications

• 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.

The full-time equivalent pay range for this position is $82,480.00 - $128,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Travel Required:
No

Shift:
Day

Duration:
No End Date

Job Function:
Quality/Regulatory