Role Purpose
The Quality Systems Engineer will serve as the primary liaison to establish, maintain, and continuously improve a robust Quality Management System (QMS) aligned with ISO 9001 / IATF 16949 standards, ensuring full compliance and audit readiness across the organization. Drive a culture of quality and continuous improvement by embedding customer and regulatory requirements into processes, while improving nonconformance and CAPA management to enhance overall performance and product quality.
Key Responsibilities
QMS Management
Develop, implement, and continuously improve the Quality Management System (QMS)
Ensure alignment with ISO 9001 / IATF 16949 standards and requirements
Monitor and control quality documentation, procedures, and records
Audits & Compliance
Plan and execute internal, external, and supplier audits
Ensure audit readiness mindset across all functions at all times
Track and ensure timely closure of audit findings and observations
Ensure adherence to regulatory, customer, and governance requirements
Nonconformance & CAPA Management
Manage nonconformance processes, including deviation handling and containment actions
Lead root cause analysis (RCA) using structured methodologies (8D, 5 Whys, Fishbone)
Drive effective corrective and preventive actions (CAPA) and verify their effectiveness
Preventive Quality Systems
Track and sustain preventive quality tools and controls (FMEA, control plans, risk-based thinking)
Identify potential risks and proactively implement mitigation strategies
Strengthen process robustness and defect prevention mechanisms
Training & Awareness
Develop and deliver QMS and compliance training programs
Promote quality awareness and audit preparedness culture across teams
Support capability development in quality tools and standards
Reliability & Validation Support
Support reliability testing and validation activities to ensure product durability and performance
Collaborate with engineering teams to ensure quality standards in product and process design
Standardization & Process Discipline
Participate in process ramp-up and stabilization, ensuring quality readiness at launch
Promote best practice sharing and replication across global sites
Monitor process compliance through layered process audits (LPA) and internal checks
Industrialization & Automation Support
Collaborate with engineering and automation teams to embed QMS requirements
Validate new processes, systems, and equipment against QMS and compliance standards
Support implementation of digital quality initiatives
Travel & Coordination
Travel to other sites to assess the audit ready program and share best practices
Act as a point of contact between central quality teams and site-level operations
Qualifications & Experience
Education: BS in Engineering, Quality Management, or related field
Experience: 15+ years of experience in Quality Systems / QMS / Compliance & Certification roles
Familiarity with manufacturing or operational environments preferred
Hands-on experience with ISO 9001 or IATF 16949 standards
Experience in audit management (internal/external/supplier)
Certification such as ISO Lead Auditor / Internal Auditor is an advantage
Skills & Competencies
Strong knowledge of Quality Management Systems (QMS) and standards
Expertise in audit processes, CAPA, and nonconformance handling
Strong analytical and problem-solving abilities
Effective communication and cross-functional collaboration
High attention to detail with a compliance and audit-ready mindset
Ability to drive training, awareness, and quality culture
Other Requirements:
Ability to travel to customer sites within the US, Mexico, India and China on a short notice.