Post-Market Quality Specialist

Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord's response to stimulation and make real-time adjustments to therapy. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.

The Post-Market Quality Specialist is responsible for the processing and management of feedback and complaints for Class III implantable spinal cord stimulation system in global markets. This role will also support Post-Market Quality data management and requests for broader QMS initiatives. The position partners closely with field teams and other quality sub-functions to ensure compliant reporting and support product performance.

Responsibilities:

• Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback, supporting all geographies


• Complaint and Feedback file management, including timely complaint intake and file closure


• Responsibility for authoring responses to regulatory agencies for additional information requests and response letters for customers following complaint reports


• Provide data inputs and analysis as needed, including monthly metrics, product trending and regulatory agency requests


• Conduct professional, HIPAA compliant, communication to internal and external parties, including end users


• Maintain and support record retention and audit readiness processes


• Participate in broader QMS initiatives and projects including supporting CAPAs and NCRs


• Drive efficiencies and process improvement for the Quality organization and cross-functionally, including frequent interaction with Supplier Quality and Customer Service

Requirements:

• Bachelor’s degree in engineering, science, technology or health OR 2+ years’ experience in the medical device industry or similar regulated environment


• Strong attention to detail, preferably with knowledge of ISO 13485 Quality Management System, database entry skills and good documentation practices


• Strong verbal communication and technical writing skills


• Individual contributor, with demonstrated organization and time management skills


• Strong aptitude for learning technical concepts


• Strong analytical and decision-making skills


• Hybrid schedule, working out of the Bloomington-MN office