We are seeking a Quality Management Systems (QMS) Engineer to join a client in Milpitas. The role is with a contract manufacturing client. This person will lead and continuously improve the Quality Management System across both New Product Introduction (NPI) and sustaining manufacturing operations. This role will ensure compliance with industry standards including ISO 9001, IATF 16949, ISO 13485, and ISO 14001, while driving quality excellence throughout our electronics contract manufacturing environment. The ideal candidate will possess strong auditing, quality systems, and continuous improvement experience, with the ability to partner effectively across engineering, manufacturing, supply chain, and customer-facing teams.
Key Responsibilities
- Develop, maintain, and continuously improve Quality Management Systems in compliance with ISO 9001, IATF 16949, ISO 13485, ISO 14001, and customer-specific requirements.
- Plan, conduct, and lead internal, external, customer, and supplier audits to ensure ongoing compliance and readiness.
- Manage the Corrective and Preventive Action (CAPA) process, including root cause investigations, corrective action implementation, and effectiveness verification.
- Maintain document control processes to ensure quality documentation is accurate, current, accessible, and audit-ready.
- Deliver training and guidance on quality standards, procedures, and best practices to promote a culture of quality across the organization.
- Monitor and analyze quality performance metrics and KPIs, driving initiatives to reduce defects, improve process performance, and enhance customer satisfaction.
- Collaborate closely with Engineering, Manufacturing, Operations, and Supply Chain teams to integrate quality requirements throughout product development and production processes.
- Ensure organizational compliance with changing regulatory, customer, and industry requirements.
- Oversee equipment calibration programs and ensure timely corrective actions for any identified deficiencies.
- Support continuous improvement initiatives utilizing industry-standard quality methodologies and tools.
- Participate in customer quality reviews, certification audits, and management review activities.
Minimum Qualifications
Education
- Bachelor's degree in Engineering, Quality Management, Manufacturing, or a related technical discipline.
Experience
- 5-10 years of quality management or quality systems experience within an electronics manufacturing or electronics contract manufacturing environment.
- Proven experience managing Quality Management Systems and supporting regulatory and certification audits.
- Experience working within NPI and high-volume production environments preferred.
Certifications
- ISO 9001 Lead Auditor certification required.
- Lead Auditor certifications in IATF 16949, ISO 13485, and/or ISO 14001 strongly preferred.
Technical Skills
- Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Project.
- Strong working knowledge of quality tools and methodologies, including:
- 8D Problem Solving
- Failure Mode and Effects Analysis (FMEA)
- Statistical Process Control (SPC)
- Advanced Product Quality Planning (APQP)
- Root Cause Analysis
- Continuous Improvement methodologies
Communication & Problem Solving
- Excellent written and verbal communication skills with the ability to effectively engage stakeholders at all organizational levels.
- Demonstrated ability to identify complex quality issues, perform root cause analysis, and implement sustainable corrective actions.
Preferred Qualifications
- Certified Quality Auditor (CQA) or equivalent quality certification.
- Lead Auditor certification in ISO 14001.
- Auditor certification or experience with ISO 13485, IATF 16949, and ISO 45001.
- Knowledge of AS9100 and ITAR regulations.
- Experience supporting aerospace, medical device, automotive, or highly regulated manufacturing environments.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.