Quality Engineer
Job Description
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/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.