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Global Quality Risk Manager

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Date: Nov 28, 2020

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  26865  

 

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.

 

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.

 

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. Consider joining our team and unlock your potential.

 

 

The Quality Risk Manager will develop and oversee Quality Management System related activities for Risk Management and ensure alignment and integration with the company’s quality system procedures and processes.  The Manager will play an integral role in designing and implementing quality risk management processes that are leveraged throughout the product life cycle and are leveraged cross-functionally throughout the organization.

 

ESSENTIAL DUTIES

  • Responsible for the development and maintenance of Global Risk Management quality procedures and applicable quality plans in compliance with ISO 13485, ISO 14971, EU MDR, CMDR, and FDA Quality System Regulations
  • Develops and implements effective training programs related to Risk Management and Post Market Surveillance to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance. 
  • Works with global QMS process owners to develop and implement risk-based strategy across the company
  • Works closely with medical safety contributors to maintain the company’s Master Harms list
  • Consults with Terumo Corporate on Risk Management best practices
  • Ensures alignment of hazard analysis across documentation for consistent decision making and actions across all functional areas
  • Collaborates with clinical affairs, quality and regulatory compliance departments to ensure appropriate monitoring and feedback through post market data.
  • Researches, sets and reports appropriate metrics to monitor the health of Risk Management procedures and processes.
  • Pursues the proactive development of new and existing business processes beyond product quality management.
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Responsible for the project and or work group expenditures vs. plan.
  • Implements and understands FDA or regulatory requirements as necessary.
  • Ensures compliance with Quality System regulations and safe working practices.
  • Plans, guides, and reviews projects and or work groups under one’s control to produce the desired outcome.
  • Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.

 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
  • Bachelor of Science or Master of Science Degree in Engineering, preferred.

 

Experience

Minimum 10 years experience.

 

Skills

  • Expert knowledge in Risk Management and Post Market Surveillance regulatory requirements.
  • Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches. 
  • Possesses a strong drive to seek and solve existing or latent problems. Maintains a consistent and resolute willingness to take ownership and accept responsibility for risk management and post market processes.
  • Demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
  • Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
  • Represents the organization as the prime technical contact on projects. Interacts with senior level external associates on significant technical matters often requiring coordination between organizations.
  • Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
  • Driver for acquiring resources and building consensus across products.
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

 

Additional Physical Requirements

Requires travel based on business needs.

 

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.


Nearest Major Market: Denver

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