Summary: We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance, regulatory compliance, and continuous improvement initiatives. The ideal candidate will have a strong background in FDA...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with a...
Responsibilities: Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones...
Summary : The Supplier Quality engineer will work closely with our suppliers and purchasing group to resolve supplier issues and prevent their reoccurrence. Applies and maintains standards for manufacturing, quality, design, testing, and i...
Summary : Ensure all packaging validation activities are properly documented and controlled. Collaborate with QA, Engineering, Manufacturing, and Regulatory teams to ensure packaging meets product and compliance requirements. Communic...
Summary: We're looking for a Sr. Manufacturing Engineer to lead and execute CNC equipment/process validation in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability, this is a ...
Job Summary: Ensure quality engineering activities for released products comply with regulatory and internal standards while supporting risk management, verification & validation, process validation, and sustaining engineering activities....
Job Description: Our LSS Designers are responsible for the delivery of complex packages in coordination with multi-disciple engineers and design leads that form the core of our Life Safety Systems delivery team. Utilizing AutoCAD and Revit...
Job Description: Our LSS Designers are responsible for the delivery of complex packages in coordination with multi-disciple engineers and design leads that form the core of our Life Safety Systems delivery team. Utilizing AutoCAD and Revit...
Job Description: Our LSS Designers are responsible for the delivery of complex packages in coordination with multi-disciple engineers and design leads that form the core of our Life Safety Systems delivery team. Utilizing AutoCAD and Revit...