Quality Engineer - Sustaining

The Quality Engineer will join our Quality Engineering team, focusing on product sustaining. This role is responsible for supporting the manufacture of high quality implantable and non-implantable spine surgery medical devices by ensuring compliance with contractual and regulatory requirements. Working closely with our NPI QE team, contract manufacturers and quality control, you will ensure only good product goes on shelve. Activities involves assessing incoming inspection methods and sampling, process controls at the contract manufacturers, facilitating nonconforming material report investigation and closure, failure investigations, CAPA and SCAR ownership, and change control activities. This role liaisons with R&D, Quality NPI, Supplier Quality, Supply Chain and Regulatory and includes continuous improvement projects

Essential Duties and Responsibilities

• Support Material Review Board (MRB).
• Develop and revise...

The Sustaining Quality Engineer, X-Ray Devices, is responsible for supporting the development and maintenance of Quality Management Systems for X-Ray Devices.  This role will support Intercompany installation teams that perform new X-Ray device installations and planned or corrective maintenance of supplied devices.   

• Be an expert in the field of quality and quality strategy for standards and regulations related to X-Ray devices in the US and outside of the US based on local and regional applicable standards and regulations, including but not limited to 21 CFR Part 1020 and 21 CFR Part 820, for the management of X-Ray emitting inventory and associated processes.  Perform and assist business customers with root cause and corrective action training, perform NCR process mentor training, confirm metric accuracy with business (quality focused) and implement common failure modes in eQMS software for extracting data and performing analysis / trending,...