Systems Quality Engineer

ORGANIZATIONAL OVERVIEW:

Gambro BCT is a world leader in automated blood collections, therapeutic apheresis, as well as an industry leader in automated blood component separation and purification technologies.

Gambro BCT provides technology, products and services to blood centers, hospitals, and scientific, clinical and biotech researchers. Gambro BCT has sales in more than 90 countries and production facilities in the U.S., and Northern Ireland, and employs 1,900 people in 30 countries. Gambro BCT’s annual revenues are approximately USD $345 million. The company is privately held.

Gambro BCT’s corporate offices are located in Lakewood, Colorado, approximately 15 minutes west of Denver.

Gambro BCT’s vision: We improve lives through innovation, quality and services delivered by our people, products and processes in blood component technologies.

Gambro BCT specializes in two market segments — blood bank technologies and therapeutic specialties.

Blood bank technologies — Gambro BCT delivers products and services that enhance blood quality, safety, supply and efficiency through automating the collection of leukoreduced red cells, platelets and plasma. Gambro BCT provides technology to automate blood component laboratories manufacturing processes of whole blood. Finally, we deliver the superior value of Mirasol pathogen reduction technology.

Therapeutic specialties — Gambro BCT delivers a range of technologies that enable advances in medicine through innovations in stem cell and white blood cell collections, cell and tissue processing, and therapeutic apheresis. Therapeutic apheresis is a process removing disease mediators or disease-carrying media from the patient. Cell therapies is the collection of blood cells, including peripheral blood stem cells and monocytes, from a patient or donor’s blood stream, then processing and re-infusing as a part of various treatments.

Gambro BCT invests in research and development to bring our customers innovative new products. Gambro BCT’s key products and systems include the Trima Accel Automated Blood Collection System, Vista Information System, OrbiSac System, Elutra Cell Separation System, COBE Spectra Apheresis System and the COBE 2991 Cell Processor.

You can learn more about the company on their website at http://www.gambrobct.com

POSITION SUMMARY:

Gambro BCT is currently seeking qualified candidates for the position of Systems Quality Engineer.

KEY RESPONSIBILITIES:

· Responsible for providing technical expertise and possible floor support for the manufacturing floor.

· Responsible for trending and correlating leading quality metrics such as data from the PDF system.

· Able to instruct manufacturing engineering about quality systems, trends, of quality data, problem solving approaches, and data analysis.

· Engineering skills are used to perform independent evaluation, selection, and application in making adaptations and modifications to projects.

· Assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.

QUALIFICATIONS:

· B.S. in Engineering with 6+ years of relevant experience.

· Understands and implements FDA or regulatory requirements as necessary (+ ISO 13485).

· Requires experience in: data analysis, teaching, problem solving, systems engineering (how functional elements interact in a systemic way).

· Requires demonstrated skills in technical innovation and technical leadership.

· Requires ISO Audit and FDA inspection experience.

 

We are proud to be an Equal Opportunity/ Affirmative Action Employer. We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. For more information about Gambro BCT visit our website www.gambrobct.com.