Manufacturing Quality Assurance Lead

Job Description

*This position is a full-time on-site role*

Our Global Operations Quality Assurance organization leads a customer-focused quality culture providing expertise, training, and consulting of quality processes for internal customers. Manufacturing Quality Assurance is responsible for the implementation, execution, and oversight of the local Quality Management System (QMS) in collaboration with our cross-functional partners.

The Folsom site maintains an ISO 9001:2015 QMS for the manufacturing of Gas Chromatography (GC) Columns and Supplies, Metal Microfluidics (MMF), Sample Preparation, and Bioconsumables. Responsibilities of the Manufacturing Quality Assurance Lead include:

• Own the local ISO 9001:2015 QMS processes in alignment with Agilent-, group-, and division-level QMS including Nonconformance Management, Corrective and Preventative Actions (CAPA), Change Control, Training, Risk Management, and Process and Equipment Validation.

• Ensure an effective Training Management process at the site with clarity for roles and responsibilities, employee qualifications, and training requirements.

• Provide Quality Assurance support to Manufacturing for production issues to ensure alignment and conformity to the appropriate QMS processes.

• Collaborate with Manufacturing and Supply Chain for product shipment holds and support Product Investigations and Field Actions.

• Continuously monitor product quality and process controls through face-to-face engagement with Manufacturing personnel to identify opportunities and support continuous improvement.

• Oversee incoming, in-process, and Quality Control (QC) inspection and approve inspection plans.

• Monitor and report Quality and Customer Experience data against established metrics. Ensure ownership and accountability of actions to address off-target or negatively trending performance.

• Lead audit management activities for the site including scope definition, audit preparation, host audits, support actions to address findings, and communicate to stakeholders.

• Represent Quality Assurance during customer interactions for QMS Questionnaires, Quality Agreements, Change Notifications.

• Support Design Transfer activities for new and revised products managed under the Product Lifecycle (PLC) process.

• Collaborate with Supplier Quality to ensure supplier management processes are effective and aligned with the site needs.

Qualifications

• Bachelor's or Master's Degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field.

• Minimum 8 years’ experience with Quality Assurance, ISO Compliance, and/or Quality Management Systems.

• Experience with ISO 9001:2015, or similar.

• Experience preparing for and hosting audits.

• Experience with multiple QMS processes: Change Control, Training Management, Nonconformance Management, Corrective and Preventative Actions, Design Control, Risk Management, and/or Validation.

• Effective communication skills with ability to work independently and collaborate with cross-functional and global teams.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least July 20, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $132,851.00 - $207,580.00/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 [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:

No

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory