The ideal candidate brings strong quality systems, auditing, structured problem-solving, and cross-functional leadership experience in a complex manufacturing environment. The role partners with Business Units and enabling functions to ensure compliance, operational excellence, and adoption of best-in-class quality practices.
Key Responsibilities
Quality Management Systems & Compliance
Lead the development, implementation, optimization, and governance of enterprise quality management systems (QMS) across multiple sites and business functions.
Ensure compliance with ISO 9001, IATF 16949, customer-specific requirements, and semiconductor industry standards.
Act as a recognized subject matter expert for quality system requirements, interpretation of standards, and best practices.
Drive harmonization and standardization of quality processes across global operations.
Audit & Certification Management
Lead enterprise internal audit programs, including planning, execution, reporting, corrective actions, and effectiveness verification.
Serve as the primary quality lead for customer audits, third-party audits, regulatory assessments, and certification audits.
Coordinate new site certifications, surveillance audits, and recertification activities across business units and enabling functions.
Analyze audit trends and systemic issues to drive sustainable corrective actions and preventive improvements.
Corrective and Preventive Action (CAPA) Leadership
Own enterprise CAPA governance processes and ensure effective management of quality issues, nonconformances, and continuous improvement initiatives.
Lead structured problem-solving activities utilizing methodologies including 4C, 8D, Root Cause Analysis (RCA), model-based problem solving, and 5 Why analysis.
Drive integration of in-line Nonconformance Reports (NCRs) into enterprise quality workflows.
Escalate systemic quality risks and facilitate resolution through cross-functional leadership and executive engagement.
Change Control & Quality Governance
Lead Enterprise Change Control Board (CCB) governance processes, ensuring appropriate risk assessments, impact evaluations, approvals, and implementation controls.
Establish and monitor key quality governance metrics to measure process effectiveness and organizational compliance.
Conduct effectiveness reviews and drive continuous enhancement of change management practices.
Partner with stakeholders to ensure quality requirements are incorporated into operational and strategic business decisions.
eQMS Ownership & Process Excellence
Serve as business process owner for assigned quality system modules, workflows, and governance processes within the electronic Quality Management System (eQMS).
Define system requirements, process improvements, enhancement priorities, and user adoption strategies.
Collaborate with IT, business leaders, and quality stakeholders to improve workflow efficiency and data integrity.
Utilize digital quality tools, analytics, and automation to increase organizational effectiveness.
Management Review & Quality Performance
Lead preparation and facilitation of ISO Management Reviews and executive quality review processes.
Develop enterprise quality performance dashboards, Quality Control Tower metrics, and management reporting tools.
Monitor leading and lagging indicators to identify risks, trends, and improvement opportunities.
Present quality performance, compliance status, and strategic recommendations to senior leadership.
Customer Quality Engagement
Manage governance processes supporting customer visits, facility tours, quality assessments, and audit activities.
Partner with customers and internal stakeholders to address quality concerns and strengthen customer confidence.
Drive proactive communication and resolution of quality-related risks affecting customer satisfaction.
Training & Organizational Development
Develop and deliver training programs related to quality management systems, audit readiness, problem-solving methodologies, CAPA processes, and governance requirements.
Mentor engineers, auditors, and cross-functional teams in quality principles and continuous improvement practices.
Promote a culture of quality ownership, accountability, and operational excellence across the organization.
Continuous Improvement & Strategic Leadership
Analyze quality trends, audit findings, CAPA effectiveness, process performance data, and business metrics to identify improvement opportunities.
Lead enterprise-level initiatives focused on risk reduction, process optimization, compliance enhancement, and operational excellence.
Influence organizational strategy through quality expertise, data-driven decision making, and best practice deployment.
Partner with senior leaders to establish long-term quality objectives aligned with business goals.
Preferred Qualifications & Experiences
Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or related technical field.
8+ years of experience in Quality, Manufacturing, Engineering, Operations, or Quality Systems.
Strong knowledge of ISO 9001, AS9100D, and/or IATF 16949 standards, quality management systems, and audit processes.
Experience leading internal audits, certification audits, customer audit readiness, CAPA programs, and quality governance activities such as Change Control Board.
Experience with document control platforms, CAPA systems, quality workflows, and quality data analysis tools.
Strong understanding of structured problem solving, root cause analysis, corrective action effectiveness, and risk-based thinking.
Experience with eQMS platforms, workflow-based quality systems, document control platforms, and CAPA systems.
Experience with MES, SPC, ERP, Power BI, and quality data analysis or manufacturing information systems.
Knowledge of risk management tools such as FMEA, control plans, process validation, process risk assessments, and risk-based thinking methodologies.
Excellent communication, organizational, facilitation, and project management skills.
Demonstrated ability to lead cross-functional initiatives and influence without direct authority.
Familiarity with semiconductor manufacturing processes and cleanroom operations.
Experience working within an Integrated Management System (IMS) environment.
Experience in semiconductor manufacturing, semiconductor capital equipment, electronics manufacturing, or other high-technology manufacturing industries.
Certified Quality Engineer (CQE), Quality Lead Auditor, Certified Quality Auditor (CQA), or similar certification.
Green Belt or Black Belt certification, IPC standards experience, and Lean methodologies experience.
Skills
8D Methodology, CAPA System, Change Control Processes, Change Management, Cross-Functional Leadership, Customer Audits, ISO 9001, Problem Solving Tools, Project Management, Quality Analysis, Quality Engineering, Quality Management, Quality Management System Auditing, Quality Management Systems (QMS), Quality Methods, Stakeholder Management, Systems Thinking
Education & Experience
Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience | Required
Pay Range
$136,200.00 - $178,815.00
Pay Range Explained
This role in Livermore, California pays between $136,200.00 and $178,815.00 per year, depending on your experience, skills, and background. Pay may vary in other locations. We offer a full benefits package, including medical, dental, vision, life insurance, disability coverage, a 401(k) with company match, employee stock purchase plan (ESPP), and paid time off. You’ll also be eligible for quarterly profit-sharing bonuses and flexible spending or savings accounts.
Equal Employment Opportunity Statement
FormFactor is an equal opportunity employer. FormFactor complies with all national, state, and local laws that seek to promote equal opportunities for any applicant or employee without regard to age, race, color, gender, gender identity/expression, national origin, sexual orientation, religion, disability, marital status, pregnancy or related condition, military service, or any other legally protected characteristics. These protections apply to all aspects of employment, including but not limited to, recruitment, hiring, training, promotions, and compensation.
For roles that are designated as remote-eligible, employees cannot be located in: AL, AK, AR, DE, GA, HI, IL, IA, KY, LA, ME, MD, MS, MO, NE, NV, NJ, NM, ND, OK, PA, RI, SC, SD, TN, WV, WI, WY. This list is continuously evolving and being updated, please check back with us if the state you live in is on the exclusion list. A role is remote-eligible only when it is listed as "Remote" in the job location.
