Quality Systems Engineer

Role SummaryThe Quality Systems Engineer is responsible for developing, implementing, and maintaining robust quality management systems to ensure that products and processes consistently meet internal standards and external regulatory requirements. This role plays a critical part in driving continuous improvement initiatives, ensuring regulatory and compliance readiness, and supporting cross-functional teams in the effective execution of quality-related processes. The Quality Systems Engineer also serves as a key contributor to operational excellence by promoting a culture of quality, risk-based thinking, and data-driven decision-making across the organization.Key ResponsibilitiesDevelop, implement, and continuously improve the Quality Management System (QMS) in alignment with industry standards and regulatory requirements (e.g., ISO, FDA).Lead internal audits and support external regulatory, certification, and customer audits, ensuring compliance readiness.Drive root cause analysis, corrective and preventive actions (CAPA), and resolution of nonconformances in a timely and effective manner.Analyze quality data and key performance indicators (KPIs) to identify risks, trends, and opportunities for continuous improvement.Support cross-functional teams in quality planning, risk management, and process improvement initiatives using Lean, Six Sigma, and structured problem-solving methodologies.Provide training and guidance on quality systems, standards, and procedures across the organization.Collaborate with suppliers and internal teams to ensure compliance with quality requirements and support ongoing quality improvements.Qualifications: Bachelor’s degree in engineering or a related field.Minimum of 5 years of experience in manufacturing or in a quality-related role.Proven experience in leading and executing manufacturing improvement projects.Strong knowledge of root cause analysis and corrective action methodologies.Familiarity with 8D or similar structured problem-solving approaches.Excellent communication skills, with the ability to effectively engage at all organizational levels, including suppliers and internal stakeholders.Proficiency in Minitab or equivalent statistical analysis tools.Fluency in English and Spanish (spoken and written).Please send your CV to sofia.viquez@ddslab.com and include your salary expectations.