Product Quality Manager

Job Description

The Product Quality Manager will oversee all aspects of product quality investigation and Post Market Surveillance compliance in BAD/CLSD/Genomics.

• Develop, implement, and manage quality investigation processes to ensure product quality issues are consistently captured, tracked, investigated, addressed and documented.
• Lead and support the CQIN, Field Action, CAPA processes execution and implementation.
• Manage the Product Quality team resources and talent development to ensure the necessary product and process knowledge are established and developed.
• Develop, manage the Product Quality dashboard to ensure the product quality status are tracked and actions are taken when trend alert or action limits triggered.
• Lead and develop Product Quality Center of Excellence, clearly define the R&R in Product Quality Investigation process, develop and implement the tools for Product Quality Investigation, develop and deliver the quality investigation training.
• Oversee the Post Market Surveillance activities and compliance to the applicable regulatory and standard requirements; Lead and oversee the PMS plan development in IVD NPI projects; Maintain and update PMS plan throughout the IVD product life cycle; Ensure the PMS reports are developed and released based on the plan.
• Work closely with CMC to ensure the complaints trending are fully investigated and documented.
• Regularly review, update, and maintain risk management file to ensure the risk assessments are up to date.
• Oversee the Annual Product Quality Review process implementation and execution in BAD/CLSD/Genomics. Ensure AQPR reports are released per plan.
• Continue driving the product quality through DEFOA, AFR, Cost of Non-Quality, customer escalation improvement.
• Support Tech Support and Product Support on customer escalated product quality issue investigation.

Qualifications

• Bachelors, Masters or University Degree or equivalent in Engineering or Scientific/Technical discipline.
• A minimum of 8 years relevant professional experience, with minimum of 3 years technical team management and development experience.
• Profound knowledge and experience of Quality Management System Standards such as ISO 9001, ISO 13485, Medical and Device Regulations (FDA QSR, IVD directive, …).
• Good understanding of QMS processes, e.g. Design control, CAPA, Product Investigation, Complaint Handling, Field Action, etc.
• Excellent analytical and problem-solving skills, data drive decision making.
• Details oriented with a commitment to maintaining high-quality standards.
• Skills in leadership, strong communication skills, and teamworking skills within an organization and across functions and/or sites
• Experience in Project Management

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least May 8, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $124,160.00 - $194,000.00/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.co