Quality Engineering Manage
Clayens US LLC
This position provides Quality Engineering support and manages company documents regarding quality issues, measurement data and measurement techniques, statistical methods and analysis, and regulatory issues. Furthermore, this position assists with adhering to record retention policies, safeguard information and retrieve data more effectively while maintaining company guidelines and new laws initiated to protect the consumer and proprietary records. This position manages the quality and regulatory aspects of mold and assembly qualification from initial customer contact, through project development, to ongoing manufacturing support. May be called upon to assist, train, or direct the project efforts of quality department staff
Provide support to project development teams regarding quality issues, measurement data and measurement techniques, statistical methods and analysis, and regulatory issues.
Review and interpret customer blueprints and specifications for measurement capability.
Communicate with customers to understand and define their quality requirements. Obtain, verify, analyze, and present necessary measurement data to evaluate conformance to specification and to prove process capability.
Conduct statistical studies of process capability and process control, and provide recommendations to product and process engineers on how to achieve capability.
Creates and maintains molding and assembly Quality Plans for new and acquisition projects. Includes specifying process-control and inspection criteria, and selecting measurement techniques.
Approves work instructions, SOPs, forms, and other QMS documents
Leads facility Material Review Board and identifies trends in nonconforming product for improvement
Works with facility process owners to manage risk mitigation efforts
Manages supplier performance review including self-audits, supplier quality manual, and corrective action processes
Store, manage and track company documents.
Organize and maintain documents, adhering to company document lifecycle procedures including archiving obsolete and inactive records.
Implement processes and tools, provide system reports, maintain and update electronic information systems, distribute approved documents, and verify accuracy of all documentation.
Manage and control the retrieval of documents; Review and edit documents submitted for revision changes or updates.
Oversee the Engineering Change Notice (ECN) process, including all ECN requests generated internally or from customers.
Responsible for maintenance and accuracy of all Job Data Packages (JDPs), including updating the documentation in a timely manner.
Update and author all Quality Management System (QMS) Documentation per the direction of the Quality Manager and all process responsible parties.
Periodically, train employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery.
Administrative tasks as needed.
Excellent interpersonal and customer service skills.
Microsoft Office Software (Word, Excel, Access and PowerPoint)
Completion of "Fundamentals of Injection Molding" Paulson Training.
English language proficiency to include verbal and written communication.
Ability to work overtime as required.
Degree in an engineering or applied science discipline preferred.
- 5-7 years’ experience in the Quality Engineering/Assurance Field with at least 2 years’ experience with plastic injection molding and a minimum of 2 years’ experience in applying SPC techniques.
- Similar quality system experience such as AS9100, ISO13485 or IATF16949 welcome.
- Computer experience with Windows, Excel, Word, and Outlook.
Medical, Dental, Vision, Life Insurance, Long Term & Short Term Disability, Critical Care and Accident Coverage, Pet Insurance, Wellness Program, Vacation, Sick Time, 401K with Match,9 paid holiday's and work/life balance...plus much more!
Monday - Friday, 8:00 AM - 5:00 PM
$70k - $80k
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