ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
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Follows all ISO 9001/ ISO 13485 Procedures and Work Instructions in the performance of the following duties:
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Develop CMM programs to support new part product launches and improvements to existing part programs. Trouble-shoot and resolve issues related to programming and/or CMM software and hardware. Develop and train additional personnel to program as need arises. Provide training to all personnel required to operate CMM. Provide preventative and regular maintenance needs for the CMM(s).
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Collect data and conduct capability studies in accordance to AIAG MSA techniques and support product launches, internal testing and development, continuous improvement projects, and customer issues.
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Assist with gage design and development as identified.
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Assist with new quality equipment purchases, implementation and training.
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Lead control plan development with cross-functional reviews.
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Conduct direct communication with customers in relation to measurement plans and inspection results in order to establish correlation during new product launch and any improvement activities in mass production.
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Develops and initiates standards and methods for inspection, testing, and evaluation in support of product launches and continuous improvement activities.
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Monitor in-process production and approve finished product by confirming specifications, conducting visual and measurement inspections, communicating required adjustments to appropriate area personnel, and documenting inspection results in PLEX when necessary in relief of Quality Control Technician
- Follow all quality procedures as required by NPI and ISO/IATF standards
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Assist with creating and updating documents and procedures as necessary
- Perform internal and layered process audits according to schedule to verify effectiveness of the Quality Management System
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Maintain safe and healthy work environment by following standards and procedures
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Develop and maintain positive working relationships across the organization
- Assist with training as assigned
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Update job knowledge by participating in educational opportunities
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Devise effective and efficient quality plans that keep processes capable and signal problems before defective parts are made
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Develop gage designs and techniques that verify product conformance through use of MSA methodology
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Set up and analyze Gage R&R and assist with data collection when necessary for measurement system analysis (MSA). Lead investigation of measurement strategy concerns coming out of MSA studies and/or other concerns that may arise.
- Review and modify testing/sampling plans based on capability rather than time intervals
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Continually monitor process data for problems and perform audits to ensure conformance to plan and technique – alert process engineering when process data indicates out of control signals so they can react properly to get it back to normal
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Fully implement all quality tools at our disposal including all PLEX controls and support manufacturing personnel as needed relative to PLEX use and reaction
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Participate in quote meetings for feasibility review of new products
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Participate in new part product launches using APQP methodology
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Ensure assigned corrective and preventive action plans are developed and executed efficiently.
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Participate in Material Review Board (MRB) meetings to determine disposition of nonconforming product.
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Perform internal and layered process audits according to schedule to verify effectiveness of the Quality Management System
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Create and manage documentation for the quality system relative to assigned processes and new product launches (FAI, PPAP, process flows, PFMEA’s, control plans, quality alerts, etc.)
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Application of GD&T standards to design and develop gages and conduct process capability studies
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Application of Minitab software in manufacturing processes to optimize processes and develop specifications based on DOE results
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Communicate with and develop suppliers, issue and track progress of corrective action requests, and complete supplier audits when assigned
- Promote a continuous improvement culture by identifying areas and processes to be considered for continual improvement, participate in continuous improvement initiatives as assigned
SKILLS NECESSARY
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Minitab
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PFMEA
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PPAP
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MSA
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SPC
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Programming Experience with CMM and Vision Systems
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Familiar with Microsoft Office – Word, Excel, Power Point
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Blueprint Reading
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Strong Understanding of GD&
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Plex ERP System (preferred but not necessary)
- Knowledge of ISO 9001 and ISO 13485
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Proactive Mentality
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Multitasking
- Organization
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Strong Communication Skills (Verbal and Written)
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Teamwork
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Minimum of high school diploma, 2 years in manufacturing environment, and 5 year experience in quality control. Experience with using an automated CMM and/or vision system is a plus. Must have the ability to work in a team environment, as well as multi-task.
The Quality Engineer plays a critical role in the function and effectiveness of the New Product Development Team and supports all levels of the quality department when necessary.
