Quality Engineer

Quality EngineerThe Quality Engineer is responsible for developing, implementing, and leading the Quality Management System (QMS) to ensure all products meet ISO 9001 standards, regulatory requirements, and customer expectations. This role drives a culture of continuous improvement and ensures the consistent delivery of high-quality products across the organization.Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach. Oversee and analyze key quality metrics, including warranty data, customer issues (CSIs), and internal nonconformance (MRRs), and lead regular quality review meetings. Provide training, guidance, and support to ensure effective root cause analysis and corrective action (CAPA) processes across the organization. Ensure company compliance with applicable global regulations, industry standards, and internal quality requirements. Partner with cross-functional leaders to drive adoption and execution of the QMS throughout the organization. Develop and implement quality programs, policies, and initiatives to improve overall performance. Prepare and present quality metrics and analysis to leadership. Lead management review processes and oversee CAPA effectiveness. Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. Review and approve key quality documentation, including procedures, audit reports, and customer-related quality agreements. Stay current on quality standards, regulations, and best practices through ongoing education and training. Lead internal and external audit activities (ISO and customer audits), including preparation and follow-up actions. Maintain and continuously improve quality documentation within the QMS. Conduct QMS training programs for employees across the organization. Support data collection and reporting to drive business decisions and operational improvements.Minimum of 5 years of experience in a similar role within a manufacturing environment. Bachelor's Degree in related field required. Engineering degree preferred. Certification in Quality and/or Lean Manufacturing required. Experience developing and maintaining ISO systems (e.g., ISO 9001, 14001, 45001, 13485). Proven experience driving continuous improvement initiatives in a Lean manufacturing environment. Six Sigma experience required; Green Belt preferred. Experience leading Kaizen events or continuous improvement workshops preferred. Demonstrated ability to influence change and drive results across cross-functional teams. Strong analytical, communication, and interpersonal skills. Advanced proficiency in Microsoft Office (Excel, Word, PowerPoint). Demonstrated potential for advancement into senior leadership roles.