Quality Systems Engineer

The Quality System Engineer is responsible for supporting and maintaining the company’s quality functions in support of manufacturing and assembly at our Santa Clara facility. This role directly supports the development and effectiveness of the Quality Management System (QMS), ensures compliance with ISO9001:2015, and ensures audit readiness across internal operations.

The Quality System Engineer will serve as the primary point of coordination for quality system administration, document control oversight, corrective and preventive actions, quality metrics, and compliance activities involving customers and third-party auditors. This individual partners closely with manufacturing, operations, engineering, and leadership to ensure products and processes meet established requirements and support continuous improvement.

Essential responsibilities include:

• Manage, maintain, and improve the company’s Quality Management System (QMS) in alignment with ISO9001 standards
• Support and help to develop quality system processes, including procedures, work instructions, forms, records control, and revision/change management
• Ensure ongoing compliance with internal standards, customer requirements, regulatory requirements, and contractual quality obligations
• Lead preparation for and response to internal and external audits, including customer audits
• Plan and conduct internal audits to verify process compliance and system effectiveness
• Track audit findings, nonconformances, corrective actions, and closure activities to ensure timely and effective resolution
• Lead or coordinate root cause analysis, corrective action, preventive action, and continuous improvement initiatives
• Monitor quality performance metrics and provide reporting to on trends and risks
• Monitor Calibration system, working with outside calibration labs to ensure all measurement devices are up to date
• Support MRB functions with cross-functional team
• Partner with internal departments to address product and process nonconformance issues
• Support inspection, quality documentation, and compliance requirements tied to manufacturing and development activities
• Oversee quality record retention, traceability, and documentation practices to ensure audit readiness and configuration discipline

• Bachelor’s degree in Quality, Engineering, Manufacturing, Operations, or related field or 5 years equivalent experience
• Strong working knowledge of ISO9001/AS9100 standards.
• Experience leading and supporting customer, government, and third-party audits
• Experience managing internal audits, corrective actions, and compliance tracking. Lead Auditor certification is a plus
• Familiarity with PPQP, including Control Plans & PFMEA
• Strong understanding of documentation control, nonconformance management, root cause analysis, and continuous improvement methods
• Ability to interpret specifications, procedures, quality requirements, and contractual compliance obligations
• Strong organizational, communication, and cross-functional coordination skills

Health insurance, Paid time off, Vision insurance, Dental insurance, Life insurance Full-time Santa Clara, CA 95050, * Dental insurance

• Health insurance
• Life insurance
• Paid time off
• Vision insurance