BD (Becton, Dickinson and Company) Manufacturing Quality Engineer in Columbus, Nebraska
Job Description Summary
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.
SPC & 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 for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions, PDN issuance for process changes, PDN sample manufacturing, microbiological environmental limits and PM compliance.
Monitor the performance of assigned product lines with regard to product quality levels, waste and rejection rates.
Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.
May obtain Black 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 department training systems.
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 rejections.
Assist in external audits and supplier certification processes as needed.
Other duties, as assigned
Expedient, accurate operation of quality engineering functions.
Dual reports to the Business Manager and Associate Quality Manager.
Has direct influence on product costs and expenditures as follows:
Approval of processing equipment for release to production.
Meeting schedules for introduction of new or modified products.
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.
Bachelor of Science degree required.
5 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.
Ability to generate validation protocols, which comply with the globalization standardization initiative.
Experience working in medical device manufacturing industry
Experience in metrology and gauge fixture design preferred.
Experience working with high performing work teams desired
Certificate in Quality Auditing
5 years practical GMP / Medical Device manufacturing experience.
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. #LI-OPS
Primary Work LocationUSA 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.