Position Overview

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.

    1. Bachelor’s Degree in Engineering, Quality Management or related science discipline. Advanced degree (MS, PhD, MBA) desired.
    2. 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.
    3. Strong knowledge of Statistical Process Control and contemporary.
    4. LEAN or Six Sigma operational excellence training or certification are highly desired.
    Desired Qualifications
    1. Bachelor’s degree required in an engineering, biomedical or related field; Master’s or Ph.D. degree is desired.
    2. Ability to develop strong collaborative relationships with all functional departments of the organization.
    3. Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions.
    4. Ability to work and communicate with all levels within the organization.
    5. Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards.
    6. Ability to effectively and efficiently manage consultants, vendors and budgets.
    7. Comfortable in a results-driven, highly accountable environment where you can make an impact.
    8. Self-motivated, able to work independently and be reliable and responsive.
    9. A team player, who listens effectively and invites response and discussion.
    10. A collaborator who communicates in an open, clear, complete, timely and consistent manner.
    11. Strong professionalism and interpersonal skills.
    12. Demonstrated practice of constructive engagement and possession of the confidence to challenge and be challenged to get the best strategies and solutions.
    13. Experience in leading change throughout an organization to enhance and sustain a world-class quality culture.
    14. Demonstrated ability to work as a senior leader and to engage the cross functional senior leadership team as needed.
    15. Demonstrated ability to lead, develop and sustain Quality team.
    16. Some experience in operations, manufacturing, and/or R&D preferred.