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Quality Engineer

Pivotal Systems
Fremont, CA Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/20/2025

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
  • 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).
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