Quality Engineer

Job Description:The Quality Engineer I will play a crucial role in ensuring that our products meet the highest standards of safety and effectiveness. This individual will support the Quality Management System (QMS) and work collaboratively with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure compliance with all applicable regulations and standards.Responsibilities:· Create and Review formal V&V documents, including Test Protocols (DVT, PV, Software V&V), Test Reports, and V&V Plans, ensuring test methods are scientifically sound and provide objective evidence of requirement fulfillment.· Provide expert guidance during the resolution of V&V non-conformances, deviations, and test failures.· In partnership with process engineers, design and author clear, concise, and user-friendly work instructions and standard operating procedures (SOPs) for in-process inspection checks at critical manufacturing stages.· Work directly with production staff to effectively deploy new inspection methods, provide training, and ensure the methods are practical and sustainable within the manufacturing environment.· Accurately read and interpret complex engineering drawings, blueprints, and geometric dimensioning and tolerancing (GD&T) specifications to ensure parts conform to all required dimensions and tolerances.· Plan and execute studies, such as Gage Repeatability and Reproducibility (Gage R&R), to validate that the developed inspection methods are accurate, precise, and reliable for their intended use.· Document inspection results, record any non-conformances, and generate comprehensive inspection reports using both paper-based and digital quality management systems.· Establish and execute procedures for recording inspection data and use this data to provide a feedback loop to engineering and production teams, driving continuous improvement and process control.· Perform detailed visual and functional inspections of finished and packaged products, verifying conformance to final specifications, workmanship standards, labeling requirements, and cosmetic criteria.· Conduct a thorough and systematic review of the completed DHR package for each batch or unit. This includes verifying the presence and accuracy of all required documentation, such as manufacturing records, in-process inspection results, material traceability, sterilization records (if applicable), and inspection reports.· Identify and clearly segregate non-conforming materials to prevent their unintended use. Initiate non-conformance reports (NCRs) and collaborate with quality and engineering teams to determine the root cause and appropriate disposition of rejected parts.· Maintain the accuracy and integrity of inspection equipment by ensuring all measuring tools are properly calibrated and handled correctly.· Execute all inspection activities in strict accordance with the company's Quality Management System (QMS), Standard Operating Procedures (SOPs), and relevant industry standards such as ISO 13485.· Facilitate communication and coordination between stakeholders, both internal and external.· Track and report on program progress to senior management, providing regular updates on key metrics and milestones.Qualifications:· A Bachelor of Science degree in Engineering (e.g., Biomedical, Mechanical, Industrial) or a related scientific field is required.· Minimum 5 years of experience in a medical device company.· Experience with and knowledge of medical device design controls and regulatory compliance (FDA, ISO, etc.).· Ability to work in a fast-paced, collaborative environment.· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is required. Experience with statistical software (e.g., Minitab) or eQMS platforms is a plus.