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.