Manufacturing Quality Engineer
Website BD
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Qualifications
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Bachelor of Science degree required
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Responsibilities
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To assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality
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To use problem solving techniques to increase quality and productivity within the Business Unit/ Department
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Essential responsibilities include but are not limited to:
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Develop, change and monitor in-process inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements
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Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address complaint issues
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Documentation of these activities along with the review and maintenance of O.I.s and department specific operating procedures such as manufacturing cleaning procedures
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Employee training of Quality Control concerns regarding specifications
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Develop and implement quality procedures applicable to the total plant manufacturing process for assigned product lines
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Coordinate efforts with Process Engineering, and Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines
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Assistance in such areas as process validation, process acceptance, certain audit correction actions
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Manufacturing, microbiological environmental limits and PM compliance
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Monitor the performance of assigned product lines with regard to product quality levels, waste and rejection rates
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Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives
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Support in the acceptance and validation of process-equipment
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Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality cost
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Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement
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Develop programs for the maintenance, replacement and improvement of inspection gauging
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Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices
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Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements
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Own and continue to improve department training systems
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Monitor customer complaints and trends
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Respond as needed for specific corrective action and customer interface
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Provide assistance and guidance on quality improvement
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Insure that all company safety rules and regulations are followed and promote general plant safety
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Assist in internal and external audits
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Other duties, as assigned
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Guidance of QC Representatives & other support personnel necessary for assigned project completion/ validations
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Expedient, accurate operation of quality engineering functions
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Reports to the Associate Quality Manager
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Has direct influence on product costs and expenditures as follows:
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Approval of processing equipment for release to production
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Meeting schedules for introduction of new or modified products
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Responsible for designing controls to minimize product costs and reduce risk of recalls and liability losses
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Must obey all safety rules
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Must follow all GMP rules
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Must cooperate fully with the safety and environmental program
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May not pose a direct threat or significant risk to himself/herself or others
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The “Essential Function” and “Other Functions” listed in this description do not restrict the addition or deletion of any other responsibilities to this position
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