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Quality Engineer willa ct as the Voice of the Customer and is responsible for ensuring that products manufactured in the facility meet all quality standards, regulatory requirements and specifactions. This role involves developing and implementing quality control systems, troubleshooting issues and collaborating with various departments to maintain and improve product quality and productivity. The Quality Engineer will also support continuous improvement initiatives and ensure compliance with industry standards, regulatory requirements and customer requirements. The Quality Engineer will also be a subject matter expert for the international standards used by their customer(s). Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements.

Job Duties:

• Quality Control Systems: Develop, implement and maintain quality control systems to ensure products meet required specifications. This includes Quality Control Plans, Inspection Procedures and Operator Instructions and setup of IQMS
  
• Inspection and Testing: Conduct inspections and testing of raw materials, in-process components, and finished products to ensure they meet quality standards
• Problem-Solving: Identify, analyze and resolve quality issues and non-conformances in the production process. Coordinate Corrective and Preventive Actions
• Process Improvement: Work with production teams to implement process improvements to enhance product quality and reduce defects.
• Documentation: Prepare and maintain quality documentation, including inspection records, test results and quality reports.
• Compliance: Ensure that manufacturing processes comply with relevant quality standards, regulations and customer requirements
• Perform measurements and data collection as required. Submit PPAP's, capability studies, IQ, OQ, PQ Validation Protocols, First Article Inspections and other data as requested by the customer for tool approval.
• Customer Interaction: Interface with customers on quality issues and provide timely and effective resolutions. This includes responding and coordinating customer complaints, RMA and other customer communications.
• Conducting and/or Coordinating containment actions. This may include traveling to customers locations for rework/sorting.
• Training: Provide training to production staff on quality standards and procedures
• Conduct Process Audits cross functionally across all three shifts
• Perform audits of data entry on Quick Inspect as needed
• Complete batch record review if required
• Complete GSD and WMJ and review with Quality Manager
• Attend weekly QE meetings
• Medical QE will conduct process validation
• Be a resource for the quality system on the production floor and quality lab
• Perform other tasks as assigned by the Quality Manager
• Understand and apply ISO 13485 Clauses to applicable role responsibilities
• Understand and apply AS9100 Clauses to applicable role responsibilities
• Follow requirements of ISO standards to maintain and improve the Quality Management System

Qualifications:

• High School diploma or GED
• Computer proficiency, measuring equipment use, blueprint reading and understanding product specifications. Self motivation, desire to succeed and not intimidated by confrontation.
• 1 year Injection Molding or 3 years in Quality Assurance with knowledge of Quality Principles
• Sitting, Standing, walking, kneeling, bending, lifting and carrying objects. Specific vision abilities required by this job include close vision requirements due to computer work. This position may require travel to customer locations.

Benefits:

• Competitive salary
• Health, dental, and vision insurance
• Paid time off (PTO)
• 401k with company match
• Paid holidays
• Life and disability insurance
• Employee assistance program
• Professional development opportunities