Specific Requirements:
Completes manufacturing related testing and processes for the Dimension RXL, EXL, and EXPAND;
Performs the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.
Enters data into internal computer systems and generates documents as required;
Interacts with others inside/outside work group: scientists, engineers and management;
Potential to work independently on projects including defining tasks, setting priorities and planning materials;
Understands the quality management system and ensures that their area complies with FDA, ISO and IVDD standards.
Knowledge of root cause investigations and performing Corrective actions.
Mathematical skills: concentration calculations and statistical analysis;
Computer skills: customary MS Office programs, SAP, LIMS, and/or Siemens Clinical testing software.
Laboratory skills: operation, maintenance and troubleshooting of analytical instruments and chemistry assays.
Demonstrated ability to work independently;
Good communication skills, both written and verbal;
Flexibility to work overtime and/or irregular work hours as needed;
Knowledge of and experience in handling bio-hazard materials;
Knowledge of QSR s and ISO standards.
Position may require participation in new product development, production support and/or reference materials.
May provide general guidance to others and train lower-level employees.
General Requirements:
Job Family Responsibilities:
Operates and performs adjustments to lab equipment and instruments. Performs quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment. Completes the compiling, analyzing, and interpreting of results. Performs periodic inspections of equipment and performs preventative maintenance work. Performs troubleshooting test processes. Performs complex calculations as well as prepares graphs and charts.
Education:
BS degree in chemistry, biology, biochemistry, or equivalent or 2 year degree with experience
Knowledge and Experience:
Successfully demonstrates thorough knowledge of a technical or specialty area. Generally, 5-8 years of successful experience in area of responsibility and successful demonstration of Key Responsibilities and Knowledge as presented above.