Description
SUMMARY:The Senior Quality Engineer will work as part of a core team supporting production and new product introduction activities. The SQE will create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards. He/She will liaise with customers to align product specifications, manufacturing procedures, test methods, and acceptance criteria. The SQE will ensure that products satisfy customer needs through design control activities, process validation, risk management, and the use of statistical methods.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Participate as a key member of new product development to ensure quality plans, specifications, manufacturing/test procedures, risk and validation documentation are established.
? Participate in design control activities, including design reviews
? Evaluate processes and technologies for reliability, capability, consistency and cost effectiveness
? Design and develop instructions and forms for recording, evaluating, and reporting quality data
? Independently design and execute experiments; utilize DOE to determine sources of variation in products and processes
? Develop validation protocols for manufacturing equipment and processes; evaluate data and write reports
? Assist in design transfer activities of new products
? Interface with suppliers to improve or resolve quality issues
? Identify and implement improvements to promote product quality and manufacturability
REQUIREMENTS:
? Bachelor's Degree with a scientific emphasis required
? Demonstrated technical proficiency, independent thought and collaboration with others
? Minimum 5 years experience in an FDA-regulated industry; 8+ years preferred, with 5+ years in Quality
? Experience in design control, validation, protocol writing and risk management
? Expertise in statistical and analytical techniques, measurement tools and process design
? Ability to read and interpret drawings and design specifications
? Excellent technical writing skills and verbal communication
? ASQ certified Quality Engineer preferred
To find out more about Real please visit www.realstaffing.com