Quality Process Analyst

at Terumo BCT

Lakewood, CO

Posted on Jul. 7, 2017

Position provides leadership and technical expertise in an emerging/changing Global Quality environment. Performs a broad range of tasks, which may include research, analysis, planning, design, validation, implementation, maintenance, supervision, and training of Global Quality processes and systems. 

  • Within the context of Global Quality, acts as project manager in various activities such as product development, design, validation of process solutions, regulatory affairs management, quality system management, customer satisfaction, technical support, and complaint management oversight (including complaint processing oversight, quality trending, and corrective action).
  • Applies business and technical knowledge when working with both internal and external suppliers in activities such as identifying options, selection, analysis, design, installation, validation, maintenance, and testing of Global Quality system solutions.
  • Responsible for providing technical assistance, problem resolution, support, and training.
  • Maintain and manage changes to Quality Systems including regular reviews and compliance of the Operations organization to this system and supports intra-company audits.
  • Oversees intra-company and external contracts for compliance to applicable regulations and adherence to the quality systems. 
  • Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 5 plus years experience desired.
  • Demonstrated ability to analyze business/technical problems and select, design, and implement solutions in accordance to business needs.
  • Demonstrated knowledge of FDA Regulations.
  • Demonstrated effective oral and written communication.
  • Demonstrated effective supervisory and leadership skills.
  • Requires the ability to lead major projects.
  • Exerts influence on business objectives and long-range goals.
  • Demonstrated knowledge of information handling systems.
  • Requires understanding of quality systems and quality management techniques and experience in developing quality measures in an effort to improve the overall product quality through design and supplier management and in-house quality systems.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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.
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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.  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 .
City:  Lakewood  
State:   Colorado (US-CO) 
Country:  United States 

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.

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