Terumo BCT Quality Specialist in Lakewood, Colorado

Quality SpecialistDate: May 3, 2018Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 13961*This is a temporarily position with the possibility of full-time hire*JOB SUMMARYWorking under very general supervision, provides quality support for abusiness by assisting management in complying with worldwide regulatoryrequirements. Performs audits, investigates complaints, reviewsrecords, and provides other services to this end.ESSENTIAL DUTIESWorks independently to accomplish established objectives and performs variedquality/regulatory activities such as the transfer/release ofsubassemblies and finished product, investigation and coordination ofcustomer product quality complaints, processing of returned goods, andperformance of regular quality system audits.Partners closely with manufacturing, engineering, and other functionalgroups on regulatory compliance issues. Develops or participates in thedevelopment of solutions to problems of moderate to intermediate complexity.Interprets, executes, and recommends modifications to operating policieswhere appropriate.Provides accurate and timely turnaround time on complaints, returnedgoods, releases, trend reports, and other activities. Maintains relatedreports that are accurate and concise.Performs detailed engineering on specific portions of broad task projectsassigned to an experienced engineer. (The work is planned to accomplishproject goals and provide experience and familiarization with engineeringmethods, independent thinking, and company practices and policies).Projects typically will require ingenuity and evaluation as well as vendorand/or customer contact.Designs and performs routine testing, project experiments, and analysis ofdata on an independent basis. Reports results.Fulfills FDA and international regulatory requirements relevant to eachproject 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 REQUIREMENTSEducationBachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.ExperienceMinimum 5 years experience.Experience in a manufacturing environment preferred.SkillsDemonstrated ability to routinely diagnose problems and recommend solutionsthrough 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, orengineering 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 technicalskill(s) or breadth.Knowledge of relevant PC software applications and skills to use themeffectively.-Or-An equivalent competency level acquired through a variation of thesequalifications may be considered.PHYSICAL REQUIREMENTSTypical Office Environment requirements include: reading, speaking,hearing, close vision, walking, bending, sitting, and occasionallifting up to 20 pounds.The physical demands described here are representative of those that must bemet by an associate to successfully perform the essential duties of this job.Reasonable accommodations may be made to enable individuals with disabilitiesto perform the essential duties.Additional Physical RequirementsMust be able to travel based on business need.We are proud to be an Equal Opportunity Affirmative Action Employer. Allapplicants will be afforded equal opportunity without discrimination becauseof race, color, religion, sex, sexual orientation, marital status,order of protection status, national origin or ancestry, citizenshipstat