Job Description The Product Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for product quality investigation and Post Market Surveillance activities for Agilent products. The daily tasks will include driving and leading product quality investigation from In Vitro Diagnostics (IVD) complaints and trend, consistently implementing high quality investigation by using appropriate root cause analysis methodologies and conducting thorough risk assessment, leading the product quality issue review with management team, and reviewing and aligning the CAPAs, Field Action, Critical Quality Incidents (CQIN) according to corporate procedures and guidance. These activities will be completed through close collaboration with other quality, regulatory, and business functions across the company. Under limited supervision/general direction and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, this position: * Applies advanced Quality and Scientific methodologies and principles to daily tasks and activities. * Applies relevant regulations, standards, GxP requirements, and industry best practices to assignments. * Acts as a subject matter expert in product quality investigation, plans and conducts product quality investigation activities with high technical responsibility. * Works closely with Complaints Management Center to ensure Genomics product complaints and trend investigations are completed on time. * Develops and drives key strategic quality initiatives throughout the organization, supports the execution of strategic vision or plan by collaborating with other quality partners to identify and standardize quality investigation competencies. * Lead and contribute the product quality investigation process implementation and improvement, as well as deliver product quality investigation training to the organization. * Establish, implement, and monitor annual product quality review (APQR) relevant product quality metrics for assigned products. * The quality engineer will also be involved with quality systems initiatives as a primary assignment or additional assignment. Generally, the projects will involve potentially greater business impact in the following areas: * Business improvement * Quality systems * Lifecycle management * Performs other duties assigned as needed. Qualifications * Bachelor's Degree in Engineering, Science, or related technical field from an accredited school is required. A relevant advanced Degree is preferred. * 8+ years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred. * Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO 14971. * Experience of working on IVD Post Market Surveillance and complaints investigation. * Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions. * Systematically driving root cause analysis with appropriate tools and methodologies (for example, DFMEA, Fishbone, Fault Tree Analysis) and Corrective Action / Preventive Action (CAPA) investigations. * Demonstrating a high level of proficiency in applying established quality tools and methods (for example, Six Sigma, Lean) to identify and realize new process introductions, as well as process and business improvements. * Experience of leading and presenting product quality issue investigation with management team. * Process and detail oriented as well as a proactive team player who's capable of working cross-functionally with people at all levels of the organization. * Full fluency in English on business level. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least May 14, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $111,840.00 - $174,750.00/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 Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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: 10% of the Time Shift: Day Duration: No End Date Job Function: Quality/Regulatory