Global Process Owner, Quality Management Systems - Post Market Compliance

Requisition ID:  32883  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The Global Process Owner QMS – Post Market Compliance is a pivotal role that significantly advances the mission to make a meaningful impact in the medical device industry. This position provides leadership in monitoring, maintaining, and continuously improving processes and supporting technology related to Quality Management System (QMS) elements. As a key process owner within the organization, the role is responsible for communicating and contributing to the development of Terumo BCT’s standardized QMS best practices. It involves developing and implementing strategies that ensure compliance with regulatory requirements while maintaining integrity and effectively managing change across the global organization. In handling post market compliance, this role drives quality excellence and contributes to significant societal impact through healthcare innovations.

ESSENTIAL DUTIES

• Process Ownership and Expertise
  • Serve as the global process owner, ensuring adherence to global regulations, standards, and processes.
  • Spearhead processes aligned with regulatory requirements and industry best practices.
  • Develop and maintain processes for tracking and analyzing post-market data to identify trends and potential areas for improvement.
  • Create and update policies and procedures to ensure compliance with regulatory requirements and industry best practices.
  • Serve as the primary contact for internal/external stakeholders on complaints management.
  • Communicate updates, resolutions, and preventive measures as needed.
• Post Market Activities
  • Oversee and manage global post-market surveillance activities to ensure compliance with regulatory requirements.
  • Lead the investigation and resolution of product complaints, ensuring timely and effective corrective actions.
  • Ensure all documentation related to post-market activities is accurate, complete, and readily accessible for audits.
• Strategic Planning and Improvement
  • Strategically plan future enhancements for QMS efficiency.
  • Evaluate technology solutions applicable to streamline processes.
  • Improve data visibility enhancing overall customer experience.
  • Implement change management strategies to align with best demonstrated practices.
  • Drive initiatives to enhance the efficiency of complaints management processes.
  • Implement feedback loops to capture lessons learned for process enhancements.
• Collaboration and Communication
  • Work closely with regulatory affairs to update processes in line with regulatory changes.
  • Lead conversations with customer service, quality assurance, legal, and product development teams to align complaint resolution processes.
  • Collaborate with cross-functional teams to document needs across departments and regions.
  • Communicate effectively to influence stakeholders and enhance understanding of QMS processes.
  • Serve as the primary contact for internal/external stakeholders on complaints management.
  • Com