Job Description Summary
The Quality Engineer provides critical quality engineering support to the manufacturing and quality operations. Working in a product family and/or common transformation process alignment, the incumbent will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality. This position provides collaborative support to quality system leadership to assure compliance with all BD quality policies, procedures and practices through consistent application of sound quality engineering/assurance
principles. Successful performance requires close work with quality management, operations, suppliers and/or BD associates.
- Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling and control plans.
- Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.
- Provides accurate and timely internal/external communication of process/production/project issues such as material inputs, process control, product quality, process/product improvements and assigned projects
- Leads and assures appropriate CAPA activities to accomplish internal/external objectives.
- Assures that new and modified equipment, materials, test procedures, measurement systems and sample plans are appropriately validated, documented and controlled.
- Formulates, reviews and implements policies and procedures relating to product quality and process control as appropriate.
- Mentors and trains project/team associates in sound quality engineering principles as appropriate.
- Stays informed of quality engineering and quality system principles focused on compliance to worldwide regulations and corporate policies with respect to medical devices.
- Bachelors degree required in science related field.
- Three (3) years experience in a high speed manufacturing environment.
- Broad background in quality.
- ASQ Certified Quality Engineer (CQE)
- ASQ Certified Quality Auditor (CQA)
- Experience with Software and Process Validation, SPC, FMEA and Risk Management.
- Experience working in medical device (ISO/QSR) or other regulated manufacturing industry.
- Experience working with cross functional teams.
- Working knowledge of automated high speed manufacturing and inspection processes and computer controls.
- Working knowledge of IQ, OQ, PQ validation phases.
- Working knowledge of industrial quality control and statistical methods for data/measurement analyses.
- Excellent verbal and written communication skills.
- Proficiency in MS Word, Excel and Project.
- Proficiency in Minitab or other statistical software.
- Indirect supervision of technicians and other support personnel may be necessary for assigned project completion
Primary Work Location
USA NE - Holdrege
1st Shift 8am-5pm (United States of America)