Vice President (VP), Global Quality
Company: Terumo Cardiovascular Systems Corporation
Location: Aliso Viejo
Posted on: April 3, 2021
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
- Provide strategic leadership and direction to global Quality
organization to ensure efficiency and compliance of company
products and processes to corporate and regulatory
- 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
- 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
- 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
- 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
- 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
- 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
- Strong organizational skills and ability to handle multiple
responsibilities simultaneously and still meet high quality and
- 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
- A team player, who listens effectively and invites response and
- 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
- Some experience in operations, manufacturing, and/or R&D
Keywords: Terumo Cardiovascular Systems Corporation, Aliso Viejo , Vice President (VP), Global Quality, Executive , Aliso Viejo, California
Didn't find what you're looking for? Search again!