Product Quality Engineer

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.

#LI-TH1

• 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