Quality Systems Specialist
Working under very general supervision, provides quality support for a business by assisting management in complying with worldwide regulatory requirements. Performs audits, investigates complaints, reviews records, and provides other services to this end.
- Works independently to accomplish established objectives and performs varied quality/regulatory activities such as the transfer/release of subassemblies and finished product, investigation and coordination of customer product quality complaints, processing of returned goods, and performance of regular quality system audits.
- Partners closely with manufacturing, engineering, and other functional groups on regulatory 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 complaints, returned goods, releases, trend reports, and other activities. Maintains related reports that are accurate and concise.
- Performs detailed engineering on specific portions of broad task projects assigned to an experienced engineer. (The work is planned to accomplish project goals and provide experience and familiarization with engineering methods, independent thinking, and company practices and policies). Projects typically will require ingenuity and evaluation as well as vendor and/or customer contact.
- Designs and performs routine testing, project experiments, and analysis of data on an independent basis. Reports results.
- Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO.
- Coordinates product builds, documentation, and release activities.
- Extreme focus to the end customer.
- Flexible schedule to accomplish primary customer.
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 5 years experience.
Experience in a manufacturing environment preferred.
- 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.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Continuous development of knowledge in physical, life sciences, or engineering theory and practice as this knowledge applies to each project.
- 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 skill(s) or breadth.
- Knowledge of relevant PC software applications and skills to use them effectively.
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.
Additional Physical Requirements
Must be able to travel based on business need.
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.
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.
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.