Senior Quality Engineer - Medical Devices

Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activityResponsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulationsIdentify and control Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actionsSupport plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for medical device productsProvide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer PlansSupport root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectationsDraft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers