Quality Engineer - Orthopedics

Quality Engineer in Orthopedics responsible for setting basic quality standards and leading efforts to develop methods for testing, sampling and training; manage process control, process validation and continuous improvement; apply statistical process control (SPC) to analyze data, design experiments, and lead CAPA investigations; coordinate with suppliers on quality issues, qualify suppliers, and contribute to supplier quality programs; build and maintain device quality documentation (DMRs, design controls, risk management, CE technical files) and support regulatory activities including 510K submissions; ensure compliance with 21 CFR 820 and ISO 13485; travel up to 15%.