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Carpinteria, California, United States
Onsite
Please note this is a hybrid role per business needs
Agilent advances the quality of life by delivering trusted answers and innovative solutions that help our customers improve human health and the world around us. As a Senior QSAT Engineer in our Clinical Diagnostics Division, you will help safeguard the quality of the pathology products that support cancer diagnostics for patients worldwide — a mission-critical role for Agilent and the QSAT Sustain team.
This is an expert-level, dual-focused role split approximately 70% product quality (investigations, CAPAs, root cause analysis) and 30% equipment qualification and validation across the product lifecycle. You will partner closely with Manufacturing QA, Field Actions, Vigilance, Post-Market Surveillance, Manufacturing, MSAT, and R&D, and report to the Manager of the QSAT Sustain team.
Lead product quality investigations from complaints, post-market surveillance, product quality reviews, and incident trending.
Drive root cause investigations for product and manufacturing issues using structured problem-solving tools.
Review, align, and approve CAPAs in accordance with divisional procedures and regulatory guidelines.
Guide qualification and validation of manufacturing equipment, processes, and change controls.
Support R&D compliance during minor design changes and product updates.
Apply advanced quality engineering principles, GxP requirements, and industry best practices.
Act as a subject matter expert and contribute to strategic quality initiatives in lifecycle management, quality systems, and continuous improvement.
Bachelor's degree in Engineering (advanced degree preferred).
8+ years of quality engineering experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical preferred).
Proven experience owning CAPA, NCR, and Supplier Corrective Action investigations to timely closure.
Strong hands-on root cause analysis and problem-solving skills (Six Sigma, Lean, 5 Whys, Fishbone).
Working knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
Ability to interpret and apply risk determinations from FMEAs and related risk documents.
Ability to review and approve complex CAPA issues to support successful audit outcomes.
Detail-oriented, process-driven, and effective working cross-functionally.
Business-level English fluency (read, write, speak).
Preferred
Experience with qualification and validation of production equipment (filling lines, washing machines, or similar).
Prior QA experience within manufacturing in a regulated industry.
Familiarity with design control and design transfer.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least July 13, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $124,976.00 - $195,275.00/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 job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.