Manufacturing Quality Assurance Lead - Folsom

Posted 25 Days Ago
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Folsom, CA, USA
In-Office
133K-208K Annually
Senior level
Biotech
The Role
Leading the site’s Quality Management System, overseeing audits, ensuring compliance, supporting manufacturing quality processes, and driving continuous improvement initiatives.
Summary Generated by Built In
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 April 29, 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/locations

Agilent 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: NoShift: DayDuration: No End DateJob Function: Quality/Regulatory

Skills Required

  • Bachelor's or Master's Degree in Chemistry, Life Sciences, Engineering, or related field
  • 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 QMS processes: Change Control, Training Management, Nonconformance Management, CAPA, Design Control, Risk Management, Validation
  • Effective communication skills

Agilent Technologies Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Agilent Technologies and has not been reviewed or approved by Agilent Technologies.

  • Retirement Support The core U.S. package highlights a generous 401(k) match as a strength. Retirement programs are positioned as competitive within the company’s total rewards.
  • Equity Value & Accessibility An Employee Stock Purchase Plan at a discount provides accessible equity and augments total compensation. Ownership opportunities are presented as a notable advantage alongside retirement benefits.
  • Leave & Time Off Breadth Flexible Time Off, company holidays, a personal holiday, and paid volunteer time create a broad leave offering. Time off can accrue into multiple weeks in the first year, supporting flexibility.

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The Company
HQ: Santa Clara, CA
17,369 Employees
Year Founded: 1999

What We Do

Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.

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