The Quality Engineer position is located at the BD-Broken Bow, NE, facility, which opened in 1960 with 55 employees. After 11 expansions, the 300,000 square foot facility employs approximately 500 associates. BD-Broken Bow is the world's largest manufacturer of Vacutainer ® tubes, shipping products worldwide, utilizing world class manufacturing techniques, driven by a combination of the latest technology, innovation, and processes.
Broken Bow, NE is a progressive community located in the heart of Nebraska experiencing recent growth in the local school systems, medical facilities, parks and recreation, as well as post-secondary educational opportunities! BD-Broken Bow is a community leader in charitable contributions to local nonprofit organizations. Many associates hold leadership positions on local and regional boards and volunteer with community and school organizations.
The quality engineer performs different compliance related duties associated with medical device manufacture at the BD site in Broken Bow, Nebraska. This position is integral to the design and maintenance of quality systems to meet and exceed ISO and FDA guidelines, while collaborating with a variety of local and international resources at all levels of the company.
This position will build and execute strategic quality plans, validation protocols, and regulatory compliant operating procedures in support of routine validation, as well as expansion and upgrade projects. Constant evolution to meet the technological needs of the healthcare industry provides the quality engineer the opportunity for project ownership and quality system design in the transfer of new processes to the Broken Bow
- Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues.
- Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
- Provides technical guidance for projects using the application of FMEA’s, risk mitigation, plant validations; DOE’s’ and other experiments and investigations as assigned.
- Lead projects using the application of continuous improvement tools and methodologies such as Six Sigma, Lean, etc.
- Works with all departments to maintain the highest quality standards.
- Formulates, reviews and implements policies and procedures relating to product quality and process control as appropriate.
- Ensures that all activities align with government (OSHA, EPA, FDA, ISO, etc.) regulations and corresponding company policies/procedures including activities and programs as defined in the Quality Systems Manual for BD Broken Bow.
- Coordinates machine and process capability studies, analyzes the data and submits recommendations.
- Designs and assists Production, Engineering and Division in the completion of new product/process evaluations including Hazard Analysis.
- Coordinates communication between Division R&D and Plant personnel on new products, product improvements and product issues.
- Participates in Engineering and Production functions as required to achieve the overall objectives of the Plant.
- Other duties as assigned, such as Internal Audits, PIR/CFI investigations.
- Supports plant safety initiatives.
- Experience with FMEA and risk mitigation.
- Experience with Value Stream Analysis and Lean Methods is highly desirable.
- Proven record of supporting and driving continuous improvement activities in a production environment.
- B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
- Solid understanding of Validations, IQ, OQ, PQ, and DOE's is desirable.
- Knowledge of QSR's/ISO 9000 and their application would be a plus.
- Black Belt/Six Sigma training highly desirable.