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
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/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: NoShift: DayDuration: No End DateJob Function: Quality/RegulatorySkills Required
- BS/MS/PhD in Science or Engineering
- Minimum 4 years working in a Quality Management role in a regulated industry with experience interfacing with regulatory bodies
- Experience with Quality Management Systems (QMS) and regulatory standards (ISO, GxP, QSR, cGMP)
- Quality experience in medical device manufacturing
- Experience initiating, supporting, and approving CAPAs and NCRs, and conducting root cause analysis
- Experience supporting audits, regulatory inspections, validation, equipment qualification, and documentation review
- Fluency with Six Sigma and/or Lean Manufacturing
- FDA and EU regulated work experience
- Ability to train, mentor junior QA staff and collaborate cross-functionally
Agilent Technologies Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Agilent Technologies and has not been reviewed or approved by Agilent Technologies.
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Retirement Support — The core U.S. package highlights a generous 401(k) match as a strength. Retirement programs are positioned as competitive within the company’s total rewards.
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Equity Value & Accessibility — An Employee Stock Purchase Plan at a discount provides accessible equity and augments total compensation. Ownership opportunities are presented as a notable advantage alongside retirement benefits.
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Leave & Time Off Breadth — Flexible Time Off, company holidays, a personal holiday, and paid volunteer time create a broad leave offering. Time off can accrue into multiple weeks in the first year, supporting flexibility.
Agilent Technologies Insights
What We Do
Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.
