Quality Systems Specialist

Requisition ID:  30775  

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. 

JOB TITLE:  Quality Systems Specialist

JOB SUMMARY

Work under limited supervision to provide quality support by assisting management institutionalize compliance with global regulatory requirements.  The Specialist must be capable of managing elements of the Quality Management Systems (QMS) to ensure timeliness of reports and compliance to the established standards. Providing support for audits, nonconformance investigations, or other services to this end may be required.

ESSENTIAL DUTIES

• Organize and manage a Quality Survey system to provide requested feedback to customers.
• Serve as the project coordinator for a given Quality System. Managing meetings involves the following responsibilities (as applicable): creating presentations, monitoring trends, analyzing data reports, ensuring timeliness on reports, writing/communicating meeting minutes, tracking action items, and presenting data to meeting attendees.
• Works closely with quality management, manufacturing, engineering, regulatory affairs, and other functional groups on regulatory as well as quality system compliance issues.  
• Develops or participates in the development of solutions to problems of moderate to intermediate complexity.  Interprets, executes, and recommends modifications to operating policies where appropriate.
• Provides accurate and timely turnaround time on investigaitons, surveys, trend reports and other activities.  Able to utilize technical writing skills to create or edit reports.  Communicate effectily to management regarding those reports.
• Organize and manage projects that typically will require ingenuity and evaluation as well as vendor and/or customer contact.
• Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO Standards.
• Perform Periodic Review of Documents:  manage or evaluate company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards. 
• Comfortable directing or supporting internal or external audits (front room and backroom duties).

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 4 years experience.

Experience in a manufacturing environment preferred.

Skills

• Time management and flexivility.
• Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Demonstrate ability to communicate effectively both verbally and in writing.
• Knowledgeable in FDA and international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO.
• Work assignments require the development of in-depth engineering or technical writing skills.
• Ability to organize and manage a multitude of projects.
• Knowledge and use of relevant PC software applications (Outlook, Teams, Word, PowerPoint, Excel, etc.) and skills to use them effectively.

-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

May be required to travel domestically on a rare occasion.

Target Pay Range:  $65,600.00 to $82,000.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• 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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.