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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. The position is largely self-directed.

Supervisory Responsibilities:

May be called upon to assist, train, or direct the project efforts of quality department staff

Duties/Responsibilities:

• 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. Negotiate requirements when appropriate. 
• Use designed experiments and FMEA techniques to identify robust processes and to improve existing ones. Obtain, verify, analyze, and present necessary measurement data to evaluate conformance to specification and to prove process capability.
• Includes oversight of calibration process to assure accuracy and correct interpretation. 
• 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. 
• Identify the need for custom gages and gage systems, obtain and qualify them, and when required, manage their design and construction. 
• Manages internal and external audit process
• 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
• Compiles and leads ISO Management Review process
• 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; receive and process Requests for Information (RFI) from employees or clients and maintain the requests via tracking logs including the creation of new templates.  
• 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. 
• File migration and auditing.
• Administrative tasks as needed. 
• Other duties as assigned.

Required Skills/Abilities: 

• Excellent Written and Verbal Communication
• Excellent interpersonal and customer service skills.
• Microsoft Office Software (Word, Excel, Access and PowerPoint)
• Must be task oriented, with the ability to adjust multiple priorities in a short period of time.
• Ability to interact with employees at all levels of the organization
• Completion of "Fundamentals of Injection Molding" Paulson Training.
• Ability to quickly build strong working relationships with business partners and colleagues
• Must be extremely organized, accurate and detail oriented
• English language proficiency to include verbal and written communication.
• Ability to work overtime as required.
• Must be able to pass all pre-employment screenings.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.

Education and Experience:

• B.S. 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.
• Background ISO9001 environment required. Similar quality system experience such as AS9100, ISO13485 or IATF16949 welcome.
• ASQ certification preferred.
• Computer experience with Windows, Excel, Word, and Outlook.