Manufacturing Quality Engineer

The Manufacturing Quality Engineer is responsible for understanding customer quality related requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical parts.
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 to by accomplishing any related tasks as needed to meet business goals.
MINIMUM QUALIFICATIONS Minimum Bachelor’s Degree in an Engineering or Science discipline.
Willing to consider alternate Bachelor Degree programs with relevant experience in excess of the requirement below.
Minimum of 5 years of relevant experience in manufacturing capacity.
Working Knowledge of ISO 9000 based requirements and related systems.
Preferable to have an understanding of GMP for Medical Devices FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Medical Devices – Quality Management Systems or experience working in a regulated industry.
Green Belt or ASQ certification a plus.
Proven problem solving experience SKILLS/COMPETENCIES: Strong interpersonal and presentation skills needed to interact with external customers as well as with all levels within the company.
Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.
Thorough knowledge and experience surrounding machining and quality inspection.
Proficiency in Microsoft Office Software, and Solidworks.
Project Management and Lean Manufacturing experience.
Good knowledge of statistical tools, ability to manage multiple tasks.
Must be flexible and adapt to changing environments and priorities.
Proven ability to collaborate in a team environment.
Demonstrated entrepreneurial skills with the ability to work effectively in a fast paced and changing environment with multiple priorities.
Excellent communication and interpersonal skills.
OTHER POSITION REQUIREMENTS Ability to work in an entrepreneurial, fast-pace and rapidly evolving environment.