Corporate Quality Engineer
Listed on 2026-06-26
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Quality Engineering
The Corporate Quality Engineer Level 2 is responsible for executing and managing corporate quality system activities, including CAPA investigations, Document Control Center (DCC) lifecycle management, and internal ISO 9001 audit execution. This role independently drives compliance initiatives, monitors QMS performance, and ensures consistent application of corporate quality standards across operations.
The Corporate Quality Management team serves as the centralized governance body responsible for maintaining the organization’s Quality Management System (QMS) and ensuring compliance with ISO 9001 standards, regulatory requirements, and internal policies. The team operates independently of product or project teams and works cross‑functionally to drive audit readiness, enforce standard operating procedures, manage non‑conformance and CAPA processes, and ensure consistent quality practices across the organization.
Duties/Responsibilities- Develop, implement, and maintain quality control and inspection processes aligned with ISO 9001 standards and corporate requirements.
- Manage the Document Control Center (DCC) lifecycle, including document review, version control, approval workflows, and compliance tracking.
- Perform root cause analysis for systemic quality failures and lead the implementation of corrective and preventive actions with minimal supervision.
- Ensure manufacturing processes comply with defined quality requirements and propose process adjustments to maintain compliance.
- Lead investigations of line rejections (LRR/VLRR), validate defect conditions, and coordinate corrective actions to prevent recurrence.
- Plan and execute internal audits and customer‑requested inspections, ensuring accurate and timely documentation.
- Monitor CAPA effectiveness and ensure proper documentation and verification to prevent recurrence.
- Plan, conduct, and document internal audits; support external and customer audits, including preparation and follow‑up actions.
- Track audit findings, NCs, and corrective action status to ensure timely resolution and compliance.
- Maintain accurate records and reporting of QMS performance, including audit metrics, CAPA status, and compliance indicators.
- Solid understanding of ISO 9001:2015 principles and manufacturing processes.
- Proficiency in Microsoft Excel for data analysis, trend reporting, and pivot table creation.
- Strong analytical and problem‑solving skills with the ability to independently interpret data.
- Ability to conduct root cause analysis (5 Whys, Fishbone) and implement effective corrective actions.
- Strong organizational skills with the ability to manage multiple priorities.
- Bachelor’s degree in Quality, Industrial Engineering, Electrical Engineering, Mechanical Engineering, or a related field
- 2-6 years of experience in corporate quality, manufacturing quality, or ISO 9001 compliance roles.
- Prior experience in an ISO 9001 certified manufacturing environment is preferred.
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