Quality Engineer

Senior Quality Engineer

The person in this position will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements for compliance. Apply best practices from within the field of quality to ensure that the materials, components, processes, and manufacturing techniques are used to produce high quality and reliable products.

Core Responsibilities:

• Own and/or support root cause determinations and execution of corrective actions per Non-Conforming Material Reports (NCMR’s) and Corrective Actions & Preventive Actions (CAPA’s)
• Understand, own, and execute risk management practices and files and ensure compliance to applicable standards.
• Facilitate environmental monitoring and ensure. Understands and executes risk management practices in relation to environmental monitoring and bioburden and relevant excursion
• Monitor and provide quality engineering support to team members performing or responsible for calibration
• Prepare and execute validations, technical studies, test method validations, and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports. Analyze and report quality system data, as needed, to the Quality and Manufacturing teams
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
• Utilize statistical techniques and six sigma tools to analyze processes to drive continuous improvement and/or identify performance changes
• Read and interpret standards in the area’s sterilization, bioburden, endotoxins, and relevant product testing for development and modification of procedures and protocols

Requirements:

• Bachelor’s Degree in Microbiology, Biology, Biomedical Engineer, or equivalent field from an accredited four year college or university
• 2-6 years of equivalent experience in a related field, preferably in Medical Device
• Functional understanding of medical device standards ISO 13485, ISO 11138-7, and ISO 14971 (associated with risk)
• Experience in using MS Word, Excel, Power Point and Outlook
• Strong oral and written communication skills