Share this Job

Quality Manager

Date: Jan 8, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22481  

 

JOB SUMMARY
Working without significant direction, managing the Product & Manufacturing Complaint/Investigation Team, supports Quality Management through advanced level activities requiring broad business knowledge. Performs a broad range of tasks which may include research, architecture planning, analysis, design, validation, maintenance, support, training, and implementation of Quality Systems, Policies, and Procedures.


ESSENTIAL DUTIES

  • Works with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues. Develops or participates in the development of solutions to problems of intermediate to high complexity.
  • Performs varied quality/regulatory activities such as developing and implementing plans and procedures to comply with applicable local, state, federal, and international regulations.
  • Interprets, executes, and recommends modifications to operating policies where appropriate. Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
  • Contributes to or leads projects for the timely completion of corrective actions.
  • Supports the implementation and maintenance of the Quality System.
  • Provides support to the internal and external audit program. Primary contact for FDA audits
  • Leads and participates in continuous improvement.

 

OTHER DUTIES AND RESPONSIBILITIES

 

  • Will participate in evaluation of complaints for adverse event reporting on a global basis and is responsible for submitting necessary reports for North America according to policies and procedures.
  • Will develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards.
  • Will assist or lead in identification, creation, implementation, and maintenance of training for QMS policies and procedures.
  • Will prepare and deliver presentations to management team.
  • Will direct supervision of professional and quality support staff including the review, evaluation, and development of reporting associates.

 

 

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.
  • 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).
  • 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.

 

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, Engineer, Telecom, Telecommunications, Manager, Healthcare, Engineering, Technology, Management