Sheehan Clint Soans
Product Quality Engineer @Philips
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WORK HISTORY
Product Quality Engineer @Philips
Böblingen, DE
Audit support for internal and external audits. • Provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies. • Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone. • Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. • Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. • Responsible for quality plans, assessing product designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving. • Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. • Lead quality related problem solving and root cause analysis during design and manufacturing.
EDUCATION
TUV SUD Academy
Advanced training, Regulatory Affairs Manager
TUV SUD Academy
Advanced Training, Regulatory Affairs Manager - International
Technical University Berlin
Master of Science, Global Production Engineering-Manufacturing
St. Joseph Engineering College
Bachelor of Engineering, Mechanical Engineering
ABOUT SHEEHAN CLINT SOANS
Experienced Quality Engineer with a demonstrated history of working in Class II - Class medical device industry. Skilled in Medical Devices, Audits, Complaints Management, Root Cause Analysis, and CAPA processes. Certified Regulatory Affairs Manager with good understanding of Regulatory requirements. Current project: New Product Development of medical devices
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