Manufacturing Quality Engineer
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 and productivity within the business.
- Essential responsibilities include but are not limited to:
- Develop, change, and monitor in-process inspections to ensure the greatest value in process 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 S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures.
- Employee training of Quality Control concerns regarding Process specifications.
- Develop and implement 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, Change Control issuance for process changes.
- Support CAPAs as owner or as part of the support team.
- Monitor the performance of assigned product lines about product quality levels, waste, and rejection rates.
- Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.
- May obtain Green/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 support and guidance on quality/ process improvements.
- Ensure 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 internal/ external audits and supplier certification processes as needed.
- Other duties, as assigned
Supervision of QC Representatives & other support personnel necessary for assigned project completion.
KNOWLEDGE AND EXPERIENCE
Required: Bachelor of Science degree
Required: 5 years manufacturing experience with broad background in manufacturing processes
- 2 years Process Control experience
- 2 years Quality manufacturing experience
- Proven history of product / process improvements utilizing Green/ 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.
Primary Work Location
USA NE – Columbus (West)