Global Quality Systems Lead — Multi-Site CAPA & Compliance

Pivotal Systems; Fremont (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Pivotal Systems in Fremont, CA seeks a Quality Manager to lead the quality organization, unify QMS across global sites, and drive CAPA and audit readiness. The role partners with engineering, production, and supply chain to strengthen quality processes and mentor staff.

The candidate will champion document control, lead supplier quality programs, and drive cross-functional improvements while traveling as needed to support audits and site alignment.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field
• 7+ years of experience in quality engineering or management building or maturing QMS
• Strong knowledge of 8D, FMEA, SPC, RCA, CAPA
• Experience with document control systems (eQMS)
• Experience unifying QMS across multiple sites
• Experience with supplier quality programs and audits
• Experience with ISO 9001 internal and external audits
• Mentor and develop junior quality staff
• Strong cross-functional communication; willingness to travel internationally

Responsibilities

• Lead Fremont's quality function as a model for the organization and support multi-site growth.
• Own and administer the document control system and implement eQMS tooling.
• Partner with global quality engineers to unify site QMS practices into a single global system.
• Lead and mentor Fremont-based quality engineering staff in process design and CAPA ownership.
• Lead supplier quality program initiatives including POR, supplier qualifications, audits, and incoming inspection policy.
• Participate in Change Control Board reviews ensuring risk assessment for quality systems.
• Represent quality in customer interactions and audits both locally and internationally.
• Support audits (ISO 9001:2015) and site readiness at Fremont, Malaysia, and Korea.
• Collaborate with engineering, production, and supply chain to resolve quality issues and drive CAPA/8D.
• Travel internationally to support site alignment and audit readiness.
• Contribute to a company-wide quality/safety alert system to empower production staff to raise concerns

Skills

Leadership

Communication

Mentoring

Process improvement

Audits

Education

Bachelor's degree in Engineering or related field

Tools

MasterControl / Arena / Qualio / ETQ

Minitab/JMP

Job description

Pivotal Systems in Fremont, CA seeks a Quality Manager to lead the quality organization, unify QMS across global sites, and drive CAPA and audit readiness. The role partners with engineering, production, and supply chain to strengthen quality processes and mentor staff.

The candidate will champion document control, lead supplier quality programs, and drive cross-functional improvements while traveling as needed to support audits and site alignment.