The Quality Engineer is directly responsible for overseeing product and process quality. The Quality Engineer maintains the following quality system functions: CAPA, product returns and servicing, nonconforming materials, receiving, in-process, and final inspections, product complaints, process environmental controls, and sterilization controls.
The position reports directly to the Quality Assurance Manager.
Key Accountabilities Quality System Execution – 60%
Accountable for executing and maintaining assigned Quality Management System (QMS) processes to ensure regulatory compliance, product quality, process effectiveness, and continuous improvement. Supports manufacturing, supplier quality, sterilization, environmental controls, CAPA, complaint investigations, inspections, and risk management while ensuring compliance with applicable quality system requirements.
Cross-Functional Operational Support – 10%
Accountable for providing technical quality engineering support to Manufacturing, Product Development, Supply Chain, and Operations by identifying quality risks, implementing process controls, supporting validation activities, resolving quality issues, coaching associates, and promoting effective quality practices throughout the organization.
Accountable for supporting assigned client projects through effective quality engineering execution, timely completion of quality deliverables, accurate reporting of quality metrics, continuous improvement initiatives, and implementation of best practices that improve product quality, regulatory compliance, operational efficiency, and customer satisfaction.
Primary Responsibilities Quality System Execution
Administer the CAPA program, including monitoring, investigation support, effectiveness verification, and compliance with internal procedures and regulatory requirements.Manage product returns, servicing activities, and complaint investigations in accordance with established Quality System procedures.Support internal, supplier, customer, and regulatory audits, including preparation, participation, response development, and follow-up activities.Conduct failure investigations involving nonconforming materials, scrap, CAPAs, complaints, and manufacturing quality issues to identify root causes and corrective actions.Support supplier qualification, monitoring, and continuous improvement activities to ensure supplier quality and regulatory compliance.Maintain product sterilization controls, environmental monitoring programs, cleanroom controls, and other assigned Quality System processes.Support receiving, in-process, and final inspection activities while ensuring compliance with inspection procedures and acceptance criteria.Support process validation, PFMEA development, manufacturing readiness, and risk management activities in collaboration with Product Development and Operations.Monitor quality records, including inspection records, lot history records, calibration records, sterilization records, and other quality documentation to ensure completeness and compliance.Recommend and implement improvements that enhance Quality System effectiveness, product quality, regulatory compliance, and operational efficiency.Cross-Functional Operational Support
Coach and train associates on Quality System procedures, process controls, inspection techniques, and quality best practices.Provide technical quality engineering support to Manufacturing, Product Development, Supply Chain, and Operations to resolve quality issues and improve process performance.Collaborate with cross-functional teams to support product development, design transfer, validation activities, and risk management throughout the product lifecycle.Promote effective communication and collaboration across functional teams to support Quality objectives and organizational success.Actively pursue self-initiated professional development opportunities beyond PLS-sponsored programs to enhance technical knowledge, quality engineering capability, and organizational impact.Client Projects
Support assigned client projects by completing quality engineering deliverables in accordance with project schedules, budgets,…
