Manufacturing facility is seeking manufacturing process engineer to support
manufacturing operations. Position will report to engineering director, protective packaging - with strong dotted line to plant manager
main responsibilities: support polymer extrusion processes, converting processes, and other regional process engineering needs.
Support new equipment qualifications, continuous improvement activities, resin formulations development, and development / implementation training programs.
Drive key performance metrics (i.E.: rate, yield, etc.) improvement by leading step change and continuous process improvement projects.
Implement lean manufacturing techniques and six sigma methodologies
process support, including methodical troubleshooting in matrix environment
solid experience in, and understanding of extrusion manufacturing, previous blown film experience a must
engineering degree required, chemical lpolvmer background preferred.
Lean and/or six sigma certification, black belt certification a plus
high potential for future leadership roles, previous management experience a plus
ability to train and coach others
strong organizational abilities including summarizing and presenting data
change management skills and application
self-starter to independently set and execute priorities
customer centric, quality "built-in" approach
penchant for creativity as well as continuous improvement
meticulous attention to detail
reply with a znote. If not for you, please do feel welcome to suggest candidates you see in this role...+15 Other Responses
Quality Management System
Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey
the manager, quality assurance & regulatory compliance will ensure overall quality
management system (qms) compliance with applicable regulatory and statutory requirements.
The successful candidate will manage the manufacturing site’s internal and external audit
functions and will coordinate activities of third party audits /visits. In addition, the manager,
quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions.
Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following:
*ensure overall qms system compliance with applicable regulatory and statutory requirements.
*perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso
13485:2003, 93/42/eec and other applicable standards to ensure corporate and
*develop and conduct effective training programs on related qa topics.
*conduct and support benchmarking activities.
*identify areas of opportunity and support continual improvement of the quality
identify, develop, and report qms metrics.
*manage internal audits, capa system, complaint handling (investigation/resolution),
a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired.
Ideal candidates should also possess the following skills/experiences:
applied understanding of cgmps, iso 9001, iso 13485, and fda qsr.
*demonstrated ability to effectively lead cross-functional/cross-plant project teams using
relevant project management tools such as ms project.
*demonstrated experience developing quality management systems, designing and
developing training programs/courses.
Experience with lean and six sigma methodology and tools.
*demonstrated auditing experience in medical device or other regulated manufacturing
environment (biotech, pharma, military, aerospace, automotive).+5 Other Responses