Quality Manager - QMS and ISO 9001 Expert

Job Title: Quality ManagerCompany: Pivotal SystemsLocation: Fremont, CAPosition SummaryThe Quality Manager will be responsible for Quality Assurance, Quality Control, and ISO 9001:2015 Quality Management Systems. This role ensures compliance with quality standards, leads audits, and drives continuous improvement initiatives across the organization.Key ResponsibilitiesThis candidate must have:Implement and maintain ISO 9001:2015 Quality Management Systems.Led and perform QMS Internal Audits and lead External ISO 9001:2015 QMS Registration Audits.Maintain the Quality Manual and Policy.Monitor, track, and improve Quality Objectives/KPIs.Identify key QMS processes and their owners.Conduct Management Reviews in accordance with ISO 9001:2015 QMS requirements.Train team members on the ISO 9001:2015 QMS.Oversee Advanced Product Quality Planning for new products and product changes.Collaborate with the Design Team on design reviews, design verification, and design validation.Work with the Manufacturing and Equipment Teams to develop DFM, DFA, and/or DFX practices.Assist in equipment selection, verification, and validation within the scope of quality.Develop and maintain documented information systems, SOPs, and work instructions.Conduct Design of Experiments (DOE) for process development and validation.Develop and maintain Quality Control Plans, PFMEA, and Process Flow Charts.Perform Measurement System Analysis, calibration, and measurement system validation.Analyze Voice of the Customer (VOC) data and translate it into functional requirements and characteristics.Collaborate with Supplier and Customer Design Teams on DFMEA and DVPR.Understand Critical to Quality (CTQ) requirements and develop inspection gauges/poka-yokes.Develop inspection methods and improve product quality KPIs.Lead 8D problem-solving meetings to develop corrective and preventive actions.Assist in supplier selection, evaluation, and performance monitoring.Onboard new suppliers and support them in developing quality and capacity.Perform statistical analysis using JMP, including:DistributionRegressionDOEGage R&RANOVAControl ChartsCapability AnalysisInitiate Six Sigma DMAIC projects to improve product quality.Monitor and train Quality Team members.Maintain and improve processes identified by the QMS.Qualifications & CertificationsEducation: Bachelor's degree in Engineering preferred.Experience:Minimum of 5 years in quality assurance and quality control.ISO 9001:2015 Lead Auditor Certification required.Skills and Knowledge:Significant problem-solving experience (DMAIC and 8D).Thorough knowledge of statistical techniques, including DOE and quality systems.Familiarity with 3Q6S methodologies.Proficiency in advanced quality tools such as APQP and FMEA.Advanced computer skills, including MS Office (Excel, PowerPoint, MS Project) and ERP systems.Strong presentation, facilitation, and interpersonal skills.Preferred QualificationsASQ Six Sigma Green Belt or CQE certifications.Experience with Statistical Process Control (SPC).Six Sigma Black Belt certification (preferred).

Created: 2025-02-12