Quality Engineer

Quality Engineer

Design, implement and maintain quality assurance protocols and methods for processing materials into finished products; Ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution; Inspect, test and evaluate the precision and accuracy of production processes and equipment; Support analysis of reports and production data to help identify trends and use quality tools to rectify negative trends; Ensure adherence to company's quality standards to reflect efficiency, reliability and performance; Assist in the creation of documentation to report issues and errors relating to the production process; Review product and process changes for qualification and validation requirements and assist in change implementations; Implement systems to ensure timely quality inspections for incoming materials, components or finished goods products, and perform inspections as needed; Conduct investigations on complaints or audit issues as quality system feedback is provided; Provide technical expertise to the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification and validation; Assist with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products; Manage quality action items for all Management of Change processes; Implement methods to inspect, test, and evaluate the repeatability and reproducibility of manufacturing processes, products, and production equipment; Determine Quality Metrics for all manufacturing procedures; and Lead CAPA activities, root cause analysis, and development of proactive actions to drive down non-conformances.

Requires a Bachelor's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, or a closely related engineering field and 3 years of experience as a Quality Engineer or closely related role. Requires experience with : Working in the medical devices industry; Working with 21 CFR 820 and ISO 13485; Supporting new product introduction & design transfer activities; Performing statistical analysis such as Normality Stability, Capability, Design of Experiment, T-tests, ANOVA, and Regression; Leading and supporting validation activities including installation qualifications, operational qualifications, and process qualifications; Drafting product validation protocols and supporting the execution of validation protocols; Conducting root cause analysis using methods such as 8D, 5Ws, and Fishbone Diagram; Experience with Thermal Plasma Spray Coating processes; Reviewing Quality Hold products & provide disposition; and Special process validations (i.e. additive manufacturing).