Manufacturing Quality Engineer

Manufacturing Process Engineer

Understand APQP and PPAP processes and perform project management responsibilities for assigned manufacturing changes or new product launch. Oversee project launch guides from start of purchase order to the finish at PPAP.

Provide Design for Manufacturability feedback to customers and coordinate with customers to implement mutually beneficial design improvements

Conduct research and development testing and validation to determine process effectiveness and compliance to quality standards

Develop or revise technical documentation to specify manufacturing processes; including but not limited to: documentation of equipment qualification, setup and maintenance procedures. Provide these documents as well as visual controls to the production floor.

Apply knowledge of metrology and GD&T to develop inspection and test methods for a wide array of products and processes

Develop control plans and sampling plans for the purposes of process control or validation for attribute, and variable data, for lot based and sequential sampling methods, based upon process data and understanding of manufacturing processes

Develop and implement equipment improvement ideas by:

• Reviewing or making recommendations of fixtures, tools and methods to meet productivity and specifications quality standards.
• Evaluating existing machinery and processes and researching novel manufacturing and metrology approaches that enhance operator performance, ergonomics, safety, capability, or efficiency of overall production.
• Completing cost estimates of implementing new tooling or justification for capital expenditures.
• Managing new equipment procurement and setup.

Understand and apply statistical concepts including but not limited to:

• Utilization of hypothesis testing, capability analysis, and other methods based on use of normal and non-normal data distributions where appropriate
• Control charting methodologies for various types of data, manufacturing processes, and desired controls
• Confidence intervals and their relation to sampling and appropriate application for given risk levels
• Practical application of ANOVA methods for Gage R&R and DoE analysis

Lead and participate in quality improvement and continuous improvement projects.

Develop/Use Key Process Indicators and statistical methods to determine process effectiveness, areas for improvement, best practices, and lead teams in driving continuous improvement.

Utilize proven lean manufacturing based analytical and troubleshooting/problem solving tools to identify opportunities for quality improvement through defect reduction, cost reduction, lead-time reduction, inventory reduction and elimination of other waste through optimizing floor layout, material flow, and documenting these improvements to manufacturing efficiencies, takt time, floor space utilization and overhead.

Lead/Drive corrective and preventive actions, and effectiveness verification activities for product quality issues

Work closely with production to ensure necessary controls are enforced for compliance with ISO and FDA requirements, and resources are available to support efficient production

Prepare reports by collecting, summarizing, and analyzing data from production, quality inspection, and customer feedback to identify trends and recommend updates and changes to processes or systems

Establish and participate in supplier qualification/development activities.

Provide technical troubleshooting/problem solving and training to production employees.

Coordinate and support cross-functional teams, quality, safety, and maintenance.

Contribute to other team efforts by accomplishing any related tasks as needed to meet business goals.