Product Quality Clinician

Key Responsibilities

• Analyze complex event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure.
• May review complaint conclusions/closure statements and/or customer letters.
• Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution.
• Analyze complex clinical evaluation reports (CER), regulatory submissions, regulatory agency requests, and/or management report including ad hoc report.
• Provide clinical input to Product Risk Assessments (PRA).
• Provide training to complaint staff on products and procedures and internal policies and procedures.
• Support Product Safety to maintain Decision Rationale Matrix (DRM) and utilize DRM for reportability.
• Maintain relevant education/training.
• Provide knowledge transfer and product training for team members.
• Other incidental duties: Maintain relevant education/training.

Skills

• Excellent facilitation, presentation, and public speaking skills.
• Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel.
• Proven successful project management skills.

Education and Experience

• Bachelor's Degree or Equivalent in related field.
• Experience in the Medical Device Industry, Quality System, and/or hospital/clinical environment (e.g., cardiac care, ICU, OR, or cardiovascular/endovascular interventions).
• Previous experience working in a large manufacturing company.