POST MARKET QUALITY SPECIALIST - Saluda Medical : Job Details

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. Saluda is a global company with headquarters in Australia and offices in the United States and Europe.The Post-Market Quality Specialist is responsible for the processing and management of feedback and complaints. This role will also support Post-Market Quality data management and requests for broader QMS initiatives.Accountabilities and Associated 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 additional information requests, device return and Complaint Response Letters
• Provide data inputs and analysis as needed, including monthly metrics, product trending and regulatory agency requests
• Conduct professional, HIPAA compliant communication to 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, when required
• Drive efficiencies and process improvement for the Quality organization and cross-functionally, including frequent interaction with Supplier Quality and Customer Service

Essential 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