| Help maintain and continuously improve QMSR and ISO 13485-compliant QMS. Support improvements to SOPs. Participate in internal audits and support external audits (FDA, supplier). Lead or support CAPA investigations. Help develop quality metrics. Partner with Operations to help ensure manufacturing processes are controlled and validated. Contribute to risk management, and sterilization validation. Support incoming inspection, nonconforming material control, and disposition. Provide Quality Engineering input on infrastructure and expansion projects. Support complaint handling, MDR reporting, and trend analysis. Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related technical field Minimum of 5 years’ of quality systems experience within medical device |
Apply via “Current Openings” |