Job Description

The Quality Lead will be responsible for managing and maintaining the Quality Management System (QMS) for Agilent’s Genomics division at the Santa Clara and La Jolla sites, ensuring compliance with ISO 13485, IVDR, MDSAP, and 21 CFR 820 regulatory requirements. This role will lead quality system initiatives, support internal and external audits, drive continuous improvement, and ensure alignment with global regulatory standards for in vitro diagnostic (IVD) products.

Key Responsibilities:

Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with ISO 13485, IVDR, MDSAP, and 21 CFR 820.

Oversee document control, training, CAPA, complaint handling, change management, risk management, and non-conformance processes within the QMS.

Drive audit readiness and lead/support internal audits, supplier audits, and external regulatory inspections.

Ensure compliance with IVDR requirements, including Post-Market Surveillance (PMS), Post-Market Performance Follow-Up (PMPF), and vigilance reporting.

Manage the Corrective and Preventive Action (CAPA) system, ensuring timely investigation, root cause analysis, and effective implementation of corrective actions.

Collaborate cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Clinical Affairs to support product lifecycle and regulatory submissions.

Provide training and guidance to employees on QMS requirements, regulatory changes, and best practices in quality compliance.

Support supplier management and oversight to ensure compliance with applicable quality and regulatory requirements.

Prepare and submit quality metrics and management reviews to senior leadership to ensure continuous quality system improvement.

Specific Tasks Per Site

Santa Clara (60%)

Audit prep and hosting

Internal, External, and Customer

Chemical release

Substrates and incoming raw material release

NCRs/DNs

Quality analyst (drive in Agile) and approver

Equipment Qualifications and Validations

Quality representative and approver

ECOs

Quality approver

CAPAs (ownership and approval)

Owner or Quality approver

Quality Metrics

Monthly site metrics for tiered metric system

Customer Complaint investigation, SCARs

La Jolla (15%)

Audit prep and hosting

Internal, External, and Customer

NCRs/DNs

Quality analyst (drive in Agile) and approver

Equipment Qualifications and Validations

Quality representative and approver

ECOs

Quality approver

CAPAs (ownership and approval)

Owner or Quality approver

Quality Metrics

Monthly site metrics for tiered metric system

Cedar Creek/non-site specific (25%)

Proactively trend quality data in a tiered metric system to identify areas of improvement

Provide strategic support for cross-functional quality improvement projects

Manufacturing quality support, as needed

Quality representative for CPE (Current Project Engineering) projects

SureFish Quality representative

Quality approver for IVDR migration efforts, including stability studies

pFMEAs review and approval

CAPA approver and Verifier for VoE

Audit support

#LI-PK1

Qualifications

Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field. A Master’s degree is preferred.

5+ years of experience in Quality Assurance within the IVD or Medical Device industry.

Strong working knowledge of ISO 13485, IVDR, MDSAP, and 21 CFR 820.

Experience in leading audits (internal/external, notified bodies, FDA, ISO, MDSAP audits, etc.).

Proficiency in risk management principles (ISO 14971) and QMS tools.

Excellent understanding of design controls, manufacturing controls, and post-market surveillance within an IVD environment.

Strong analytical, problem-solving, and decision-making skills.

Excellent communication and leadership abilities, with experience in cross-functional collaboration.

Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or RAC (Regulatory Affairs Certification) are a plus.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least July 28, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $117,504.00 - $183,600.00/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: Occasional

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory