Job Title: Sr. Quality Engineer

Company: Pivotal Systems

Location: Fremont, CA

Position Summary

The Quality Engineer 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 Responsibilities

• Implement and maintain ISO 9001:2015 Quality Management Systems.
• 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:
• Distribution
• Regression
• DOE
• Gage R&R
• ANOVA
• Control Charts
• Capability Analysis
• Initiate Six Sigma DMAIC projects to improve product quality.
• Monitor and train Quality Team members.
• Maintain and improve processes identified by the QMS.

Qualifications & Certifications

• Education: 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 Qualifications

• ASQ Six Sigma Green Belt or CQE certifications.
• Experience with Statistical Process Control (SPC).
• Six Sigma Black Belt certification (preferred).