Share this Job

Global Quality Manager

Date: Aug 10, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23554  

 

JOB SUMMARY

Leads specified Quality Management Systems team supervising detailed work on a specific portion of a broader task assigned to experienced quality specialists. The Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS area(s) of responsibility.  Support and improve various Quality System processes to maintain regulatory compliance.

 

ESSENTIAL DUTIES

  • QMS areas of ownership, management, and responsibility may include (as assigned):  CAPA, Audit (internal, external, supplier), Post Market Surveillance (recalls / field actions, product risk review, post-market data review), Quality System Training, Document Control, Management Review, etc.
  • Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
  • Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective. 
  • Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations.  This likely includes:  generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
  • Monitors the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.

Identifies and implements continuous improvement opportunities within their area(s) of responsibility.

  • Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
  • Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
  • Manages team of direct reports in support of the above (as applicable).
  • Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
  • During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
  • Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

 

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.

 

Experience

  • Minimum 5 years experience.
  • Candidate must have experience in the post market process.  Specifically, candidate must be experienced and knowledgeable in the Field Action process, including execution and advising the organization globally on such requirements.
  • Preferred minimum 7 years experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls. 
  • Minimum 2 years supervisory experience.
  • Preferred training in FDA Quality System Regulation and ISO 13485.

 

Skills

  • Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485).
  • Post Market Surveillance process, and knowledge of EU MDR requirements in this regard would be a plus.
  • 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, quality specialists, and management.
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Must be detail oriented, well organized and able to work independently and in teams.
  • Demonstrated ability to lead people and get results through others.

-Or-

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

 

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

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

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

Job Segment: Medical, Telecom, Telecommunications, CAPA, Manager, Healthcare, Technology, Management