Quality Engineer
Apply NowCompany: Pivotal Systems
Location: Fremont, CA 94536
Description:
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
Qualifications & Certifications
Preferred Qualifications
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).