Quality Engineer, Sustaining

Quality Engineer

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 the shelf.

Activities involve 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 inspection methods, gages and associated drawings and procedures.
• Support Engineering Change Order Review.
• Perform Design For Manufacturing activities (DFM).
• Technical interface with contract manufacturing

• Support suppliers in performing IQ, OQ and PQ processes
• Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
• Lead Risk Management efforts in accordance with ISO 14971.
• Lead continuous improvement projects
• Participate in FDA, ISO, and other regulatory audits.

• Other duties as assigned.