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Vice President (VP), Global Quality

Company: Terumo Cardiovascular Systems Corporation
Location: Aliso Viejo
Posted on: April 3, 2021

Job Description:

Vice President, Global Quality will provide leadership and overall strategic direction to Quality Department that support organization within a Class II-III, medical device development environment to ensure compliance with regulatory requirements as well as alignment with company objectives and Quality standards. As dynamic, resourceful and strategic thinker he/she will provide results-oriented leadership to sustain and improve a world class robust and efficient Quality organization. VP Global Quality will be a member of executive management team reporting to Senior Vice President, Regulatory Affairs, Clinical Research and Quality and will supervise a global organization encompassing product development and multiple manufacturing sites worldwide. Job duties:

  • Provide strategic leadership and direction to global Quality organization to ensure efficiency and compliance of company products and processes to corporate and regulatory requirements.
  • Participate in development and lead the execution of Quality strategies and goals commensurate with the Company objectives.
  • Lead the implementation of strategies to sustain and improve a global Quality organization to support the product lifecycle management from concept to product realization followed by post market surveillance to ensure business compliance, growth and sustainability.
  • Lead continuous improvement processes to enhance operational efficiency and efficiency of global Quality systems aligned with FDA and global regulatory requirements.
  • Provide strategic oversight of all segments of Corporate QMS.
  • Lead the continuous evaluation of all Quality systems and processes and recommend and direct implementation of appropriate enhancements to ensure the achievement of the Company's near-term and long-term objectives.
  • Provide guidance and direction in regulatory inspections and audits.
  • Interface directly with FDA, Notified Bodies, and other regulatory agencies on matters pertaining to processes, products or Quality systems compliance.
  • Lead the development and tracking of company quality indicators utilizing contemporary statistical tools and methodologies.
  • Provide expertise and guidance in interpreting government regulations and guidelines related to QMS and regulatory compliance as they apply to products and practices.
  • Ensure that the organization is trained to the highest standards of Quality excellence and technical competency utilizing best in class processes and practices.
  • Oversee the development of a risk assessment strategy reflective of the Company's philosophy and approach to assessing and managing risk.
  • Lead recruitment and efforts to retain and develop first class talent responsible for providing Quality support to all company operations.
  • Establish the culture to build and sustain employee engagement by fostering efficient execution of strategies and a coaching environment in which individuals and teams can excel and continuously grow. Qualifications
  • Bachelor's Degree in Engineering, Quality Management or related science discipline. Advanced degree (MS, PhD, MBA) desired.
  • Twenty (20 +) years of experience in medical device quality operations, quality assurance, quality systems, and/or compliance role with 8-10 years in a senior Quality leadership role with increasing responsibility (less years of experience might be considered with advanced degree); experience with implantable medical devices strongly preferred.
  • Strong knowledge of Statistical Process Control and contemporary.
  • LEAN or Six Sigma operational excellence training or certification are highly desired.
    • Bachelor's degree required in an engineering, biomedical or related field; Master's or Ph.D. degree is desired.
    • Ability to develop strong collaborative relationships with all functional departments of the organization.
    • Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions.
    • Ability to work and communicate with all levels within the organization.
    • Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards.
    • Ability to effectively and efficiently manage consultants, vendors and budgets.
    • Comfortable in a results-driven, highly accountable environment where you can make an impact.
    • Self-motivated, able to work independently and be reliable and responsive.
    • A team player, who listens effectively and invites response and discussion.
    • A collaborator who communicates in an open, clear, complete, timely and consistent manner.
    • Strong professionalism and interpersonal skills.
    • Demonstrated practice of constructive engagement and possession of the confidence to challenge and be challenged to get the best strategies and solutions.
    • Experience in leading change throughout an organization to enhance and sustain a world-class quality culture.
    • Demonstrated ability to work as a senior leader and to engage the cross functional senior leadership team as needed.
    • Demonstrated ability to lead, develop and sustain Quality team.
    • Some experience in operations, manufacturing, and/or R&D preferred.

Keywords: Terumo Cardiovascular Systems Corporation, Aliso Viejo , Vice President (VP), Global Quality, Executive , Aliso Viejo, California

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