BD (Becton, Dickinson and Company) QE Complaints Lead in Columbus, Nebraska
Job Description Summary
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. To use problem solving techniques to increase quality by analyzing the customer complaints, trends and patterns
Essential responsibilities include but are not limited to:
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.
Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address complaint issues.
Documentation of these activities along with the review and maintenance of O.I.s and department specific operating procedures such as manufacturing cleaning procedures.
Employee training of Quality Control concerns regarding specifications.
Develop and implement quality procedures applicable to the total plant manufacturing process for assigned product lines.
Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities .
Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.
May obtain Green Belt Certification
Assist in the acceptance and validation of process equipment.
Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality cost.
Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement.
Develop programs for the maintenance, replacement and improvement of inspection gauging.
Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices.
Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
Own and continue to improve the complaint process
Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface.
Provide assistance and guidance on quality improvement.
Insure that all company safety rules and regulations are followed and promote general plant safety.
Own and lead efforts to reduce and eliminate customer complaints.
Assist in internal and external audits as needed.
Communication to all levels.
Other duties, as assigned
KNOWLEDGE AND EXPERIENCE
Bachelor degree required
2 years manufacturing experience with broad background in manufacturing processes
2 years Process Control experience
2 years quality assurance/control experience
Proven history of product / process improvements utilizing Black Belt/Six Sigma techniques.
Experience working in medical device manufacturing industry
Experience working with high performing work teams desired.
Expedient, accurate operation of quality engineering functions.
Reports to the Quality Manager.
Has direct influence on product costs and expenditures as follows:
Expedite processing of complaints.
Meeting schedules on complaints investigation
Responsible for designing controls to minimize product costs and reduce risk of recalls and liability losses.
Must obey all safety rules.
Must follow all GMP and GDP (if applicable) rules.
Must cooperate fully with the safety and environmental program.
May not pose a direct threat or significant risk to himself/herself or others.
The “Essential Function” and “Other Functions” listed in this description do not restrict the addition or deletion of any other responsibilities to this position.
Management reserves the right to change any and all job descriptions without notice as business conditions dictate.
Primary Work Location
USA NE - Columbus (West)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.