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Director - Software Quality Assurance

Company: Hill-Rom
Location: Cary
Posted on: January 14, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • QMR Responsible for Leadership of the entire Quality System for Care Communications, including Product Commercial Release, Post Market Surveillance and Corrective and Preventive Actions--
  • Leadership and development opportunities for Quality/Regulatory associates--
  • Serves as a member of the Care Communications Leadership Team as the representative for the QA/RA function--
  • Serves as FDA Quality Management Representative facilitating company audits and Quality Management Reviews--
  • Ensures appropriate controls (measured by key metrics) are defined, implemented and satisfactorily completed for all Care Communications business operations--
  • Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction--
  • Provides training resources to ensure proper implementation and use of quality tools and procedures as required--
  • Enables rapid and effective correction of quality/regulatory problems in a manner that prevents recurrence--
  • Provides customer correspondence in response to quality issues, inquiries, or requests--
  • Evaluates compliance risks and develops risk mitigation strategies for the business--
  • Provides regulatory oversight for new product development activities, including regulatory assessments, risk assessments, etc.--
  • Coordinates submissions to governing regulatory agencies--
  • Oversees field corrections and removals for Care Communications products--
  • Manages supplier quality activities, i.e. supplier evaluations, audits, and corrective actions--
  • Reviews and approves clinical research and field validation activities for Care Communications products-----
    • BS in engineering or other technical disciplines, software related degree preferred.--
    • Minimum 10 years of experience in Quality Assurance or Regulatory Affairs, software as a medical device experience preferred.--
    • Successful record of leading people and complex projects.--
    • Minimum of 5 years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence).---

Keywords: Hill-Rom, Cary , Director - Software Quality Assurance, Executive , Cary, North Carolina

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