Quality Assurance Engineer

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 internal auditor when is needed

Technimark is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or protected veteran status.

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