Quality Assurance Engineer

Job Summary
Understanding customer expectations from new product development continuing through fulfillment of production requirements. Communicating customer expectations and requirements to appropriate personnel. Ensuring all customer expectations and requirements can be fulfilled by all facets of Technimark, through validation activities and compliance to policies, procedures and work instructions. Provide guidance for ISO 9001, ISO 13485, 21 CFR Part 820, system auditing, process improvement, and the use of statistical methods to aid the appropriate business unit and the Management Team in the optimization of the system. This position requires an in-depth knowledge of Quality Engineering. Work is performed with a high degree of independence.
Essential Duties & Responsibilities
• Reviewing requirements, specifications and technical design documents to provide timely and meaningful feedback
• Facilitate Master Plan for qualification and validation of products and processes
• Responsible for understanding and conveying customer (internal and external) expectations
• Provide validation support to project teams during all phases of product validation. This will include management of the approval process for production qualification with system set up, development of validation plans, verification and submission of IQ/OQ/PQ to meet customer expectations
• Support FMEA’s identifying critical issues and risk variables conducted by the new product development group through the life of the product
• Development of control plans based on process flows and PFMEA’s
• Facilitate training on internal and customer product expectations to production
• Continually study the existing systems using quality tools to analyze and identify areas for improvements.
• Support project teams with any function necessary to assure timely completion of the project
• Help expedite inspections when required
• Work with outside contractors to make sure that there is adequate staffing to get the required inspections completed when needed.
• Develop measurement methods for difficult Inspections.
• Assist the other Inspectors in the development of inspection methods.
• Perform D.O.E. if necessary
• Provide support for dimensional inspections for modified and full first articles.
• Provide support with capability studies.
• Review results of MFA’s, FFA’s, capability studies and gage R&R’s with appropriate personnel
• Understand critical issues and ensure proper validation of those issues.
• Author validation protocols for qualification and validation of products and processes using an IQ OQ PQ structure.
• Manage approval process for production qualification.
• Verify that all validation activities are completed to acceptance criteria documented in validation protocols.
• Perform other related tasks as needed
• Provide support as needed with the Quality Management System within El Paso, TX
Competencies
• Bilingual English / Spanish
• SPC and Gage R&R technical knowledge
• GD&T knowledge
• Technical writing
• Understanding of injection molding process
• DOE for injection molding
• Communication Proficiency
• Problem Solving/ Analysis