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Post Market Quality Specialist

2 months ago

Minneapolis, Minnesota, United States Saluda Medical Full time
Job Overview

Saluda Medical is a pioneering company in the field of closed-loop Spinal Cord Stimulation (SCS), a groundbreaking therapy that measures the spinal cord's response to stimulation and makes real-time adjustments to treatment.

The Post-Market Quality Specialist plays a crucial role in the company's success by processing and managing feedback and complaints. This position also supports Post-Market Quality data management and requests for broader Quality Management System (QMS) initiatives.

Key Responsibilities
  • Regulatory Compliance: Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback, ensuring compliance across all geographies.
  • Complaint and Feedback Management: Manage complaint and feedback files, including timely intake and closure, to maintain a high level of customer satisfaction.
  • Additional Information Requests: Handle additional information requests, device returns, and Complaint Response Letters in a timely and professional manner.
  • Data Analysis and Reporting: Provide data inputs and analysis as needed, including monthly metrics, product trending, and regulatory agency requests.
  • Communication and Collaboration: Conduct professional, HIPAA-compliant communication with external parties, including end-users, and collaborate with cross-functional teams to drive process improvements.
  • Record Retention and Audit Readiness: Maintain and support record retention and audit readiness processes to ensure compliance and efficiency.
  • QMS Initiatives: Participate in broader QMS initiatives and projects, including supporting Corrective Action Preventive Actions (CAPAs) and Non-Conforming Reports (NCRs), as required.
Requirements
  • Education and Experience: Bachelor's degree in engineering, science, technology, or health, or 2+ years' experience in the medical device industry or a similar regulated environment.
  • Skills and Qualifications: Strong attention to detail, knowledge of ISO 13485 Quality Management System, database entry skills, and good documentation practices. Strong verbal communication and technical writing skills, with the ability to work independently and as part of a team.
  • Work Environment: Hybrid schedule, working out of the Bloomington-MN office, with opportunities for professional growth and development in a dynamic and innovative company.