Quality Engineer

Overview

Quality Engineer acts as the Voice of the Customer and is responsible for ensuring that products manufactured in the facility meet quality standards, regulatory requirements, and specifications. 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 supports continuous improvement initiatives and ensures compliance with industry standards, regulatory requirements and customer requirements.

The Quality Engineer is 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, SOPs, cGMP and Management System requirements.

• 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.
• Data and PPAP:
  Perform measurements and data collection as required. Submit PPAPs, 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, including responding and coordinating customer complaints, RMAs and other communications.
• Containment:
  Conduct and/or coordinate containment actions. This may include traveling to customer locations for rework or sorting.
• Training:
  Provide training to production staff on quality standards and procedures.
• Audits:
  Conduct process audits cross-functionally across all three shifts and perform audits of data entry on Quick Inspect as needed.
• Documentation and Review:
  Complete batch record review if required; complete GSD and WMJ and review with Quality Manager.
• Meetings and Validation:
  Attend weekly QE meetings;
  Medical QE will conduct process validation.
• Quality System Support:
  Be a resource for the quality system on the production floor and in the quality lab.
• Other Tasks:
  Perform other tasks as assigned by the Quality Manager.
• Standards Knowledge:
  Understand and apply ISO 13485 Clauses to applicable role responsibilities.
• Standards Knowledge:
  Understand and apply AS9100 Clauses to applicable role responsibilities.
• Quality Management System:
  Follow requirements of ISO standards to maintain and improve the Quality Management System.

• 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.

• 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