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 Genomics and BAD reagent and consumable products.

The daily tasks will include driving and leading product quality investigation from 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, CQIN according to corporate procedures and guidance, manage PMS activities for GenetiSure Dx and other Genomics IVD products.

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, Tech Support, other key stakeholders to ensure Genomics product complaints and trend investigations are completed on time.

Develop, release, maintain, manage Post Market Surveillance plan and report for Genomics IVD assay products (GenetiSure Dx).

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, in Genomics and BAD, as well as deliver product quality investigation training to the organization.

Establish, implement, and monitor APQR relevant product quality metrics for Genomics reagent 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.

This position will report into Product Quality Manager for BAD, Genomics, and CLSD.

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Qualifications

Bachelor’s degree in chemistry or biology engineering, science, or related technical field or major from an accredited school is required. A relevant advanced degree is preferred.

A total of 4+ years of work experience is expected. Experience working on ChemBio reagent development, manufacturing, quality 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.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least March 13, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $97,920.00 - $153,000.00/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 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.

Travel Required: 10% of the Time

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory