Quality Engineer Supervisor in Alajuela at Theragenics Corp

PURPOSE OF JOB

Responsible for supervising and developing Quality Engineers while providing technical leadership for validation, continuous improvement, CAPA, nonconformance, and quality-system activities. The position ensures that quality engineering support is risk-based, timely, compliant, and aligned with business and customer requirements.

JOB OPERATION/ELEMENTS

Responsibilities

Supervise Quality Engineers, assign priorities and workload, monitor deliverables, provide technical direction, and support timely completion of departmental objectives.Provide coaching, mentoring, and performance feedback to assigned engineers; identify development needs and promote technical growth, accountability, and succession readiness.Lead and/or support process, product, equipment, software, test-method, and product-transfer validation activities, including IQ, OQ, PQ, engineering studies, and revalidation, as applicable.Write, review, and approve validation plans, protocols, reports, statistical analyses, sampling rationales, deviations, and related documentation to ensure technical accuracy, traceability, and compliance with approved requirements.Lead or act as CAPA owner for assigned corrective and preventive actions, ensuring robust problem definition, containment, root-cause analysis, action implementation, effectiveness verification, and timely closure.Provide technical support and mentorship for CAPAs, NCMRs, deviations, out-of-tolerance events, complaints, and other quality investigations, promoting consistent use of root-cause and risk-analysis tools.Review and approve investigations and quality records, ensuring conclusions are supported by objective evidence and that product impact and regulatory risk are appropriately assessed.Lead continuous-improvement projects focused on reducing nonconformances, scrap, rework, cycle time, recurring quality events, and process variation.Use Lean Six Sigma, DMAIC, statistical methods, Poka-Yoke, Measurement System Analysis, process capability, and other appropriate tools to improve process performance and quality-system effectiveness.Partner with Manufacturing, Engineering, Operations, Regulatory, Document Control, and Corporate Quality to resolve technical issues and maintain alignment on priorities and quality requirements.Ensure manufacturing processes and quality-engineering activities comply with applicable quality-system procedures, ISO 13485, FDA Quality System Regulation requirements, customer requirements, and other applicable standards and regulations.Support internal, customer, and regulatory audits by preparing objective evidence, responding to technical questions, and supporting the development and completion of corrective actions.Develop and maintain procedures, work instructions, templates, and training materials needed to implement quality and validation requirements.Prepare and present project status, quality risks, investigation conclusions, validation results, and improvement outcomes to management and cross-functional teams.Promote a strong quality culture by reinforcing that quality ownership is shared across functions and by modeling ethical, compliant, and risk-based decision-making.Perform additional duties as assigned.