Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Duties and Responsibilities
-Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of Quality problems.
-Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for electronics, or other types of production.
-Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
-Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
-Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
-Prepare, maintain, or review validation and compliance documentation such as engineering change notices, schematics, or protocols.
-Resolve testing problems by modifying testing methods or revising test objectives and standards.
-Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
-Identify deviations from established product or process standards and provide recommendations for resolving deviations.
-Direct validation activities such as protocol creation or testing.
-Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
-Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
-Design validation study features, such as sampling, testing, or analytical methodologies.
-Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
-Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
-Procure or devise automated lab validation test stations or other test fixtures and equipment.
-Maintain validation test equipment.
-Draw samples of raw materials, or intermediate and finished products for validation testing.
-Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
-Assist with NPI Programs
-Other duties and responsibilities as assigned (includes all non-essential or non-major activities)
Physical Requirements and Work Environment: While performing the duties of this job you may be asked to intermittently sit, stand, walk, lift or carry component parts weighing up to 33 pounds, lift parts in excess of 33 pounds with a lift assist, use hands to handle or feel parts, reach with hand and arms, stoop, kneel, crouch, bend at the waist, talk and hear, use close vision, distance vision, color vision, depth perception, peripheral vision, work on the production floor as needed, frequent phone use and keyboarding.
Minimum Level of Education and Training Required
-Bachelor’s Degree in Engineering, Engineering Technology, or Related Field
-Other relevant education, experience, or combinations thereof may be substituted in part or whole for listed minimum education
-Basic understanding in auditing IMDS/SoC Compliance
-Basis understanding of ISO 9001:2015