Quality Systems Specialist

at Terumo BCT

Denver, CO

Posted on Jun. 11, 2016

Terumo BCT is currently seeking qualified candidates for the position of Quality Systems Specialist, which is responsible for performing audits, investigates complaints, reviews records, and provides quality support for a business by assisting management in complying with worldwide regulatory requirements.
ESSENTIAL DUTIES

* 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
EDUCATION
Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Preference would be a bachelor's degree in science.
EXPERIENCE
Minimum 5 years experience.

* Experience in a manufacturing environment preferred.
* Ability to interpret and adapt guidelines and interact with regulatory agencies.

SKILLS

* Demonstrated ability to carry out a wide range of projects and resolve complex problems.
* 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 a strong 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 and use of relevant PC software applications 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
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, 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.

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