Quality Engineer

Quality EngineerOn site 5 days. 9 panel drug test requiredMust Have1-3 years' experience in medical device or pharmaceutical manufacturing1-3 years validation experience in medical device or pharmaceutical industriesResponsibilitiesProvide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.Provide statistical data analysis in support of investigations and continuous improvement projects.Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigationsManage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.Monitor Environmental conditions at Distribution Centers to protect product integrity.Implement and manage controls for temperature, humidity, and other critical parameters.Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.Prepare for and support both internal and external audits.Address audit outcomes swiftly and effectively to maintain compliance.Spearhead investigations into any quality deviations, non-conformances, or customer complaints.Implement corrective actions to prevent recurrence and enhance quality.Directly participate in quality investigations, including owning those investigations to closure.Act as a reviewer and approver of quality investigationsMaintain controlled procedures within calibration, validation, environmental controls, change control and risk management.Ensure data from environmental controls is maintained in centralized repository.Manage change control processes to ensure seamless transitions and compliance.Lead change control process for designated sites.Required QualificationsBachelor's degree in engineering2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.Preferred QualificationsMaster's degree in engineeringASQ CQA or CQE certificationExperience with Boards of Pharmacy, licensing, and regulatory submissionsExperience as a designated representative with state boards of pharmacy2-3 years' experience with ISO 13485, certification preferredSkillsExcellent problem-solving skills with the ability to think critically and creatively.Experience working with ERP systems.Knowledge of FDA regulations and ISO standards related to medical device manufacturing.2- 3 years' experience with ISO 13485, certification preferred