Job Description2nd Shift Hours: Monday - Friday 4:00pm - 12:00amJob Duties and TasksPerforms and documents dimensional inspections on parts per order specifications and company quality control policies.Detect and tag Non-conforming parts and isolated in red bins.Evaluates data to identify deviation from specifications.Prioritizes daily workload based on production schedule and product priority.Receives requests from staff and reviews drawings for accuracy prior to release.Assist in the evaluation of work performed by secondary operators as needed.Records test data applying statistical quality control procedures as required.Completes functions required for MRB such as obtaining required signatures, following through with disposition of rejected materials and data entry as needed.Recommends modifications of existing quality and production specifications to achieve optimal quality.Understand and work toward Quality objectives and cost containment, responsible for continually optimizing inspection through-put and identifying quality bottlenecks hindering the production process.Key Skills, Knowledge and Competencies:General knowledge and understanding of ISO 13485 and FDA 21 CFR 820 as it pertains to Inspection.High School or equivalent. At least 3 years' experience in Quality Control or Quality Assurance position at a Medical device manufacturer and 1-year experience as an inspector.Ability to read blueprints and customer/internal specifications.Detailed knowledge of using precision measuring instruments including, but not limited to, calipers, ID and OD micrometers, depth gages, indicators, and plug and tread Go/No Go gauges.Detail Oriented as shown by documented measurement accuracy.Proficient English communication skills - reading, writing, and speaking - as it relates to the job; Spanish a plus.Provide verbal instruction and training to quality personnel and operators on implementation of inspection methods and proper documentation.Skilled in basic math including but not limited to adding, subtracting, multiplication, division, and basic algebra for the purpose of calculating specifications.Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events.Skilled in setting priorities that move projects through efficiently - achieving customer and quality objectives.Skilled in working independently, following through with assignments with minimal direction.Reasoning skills including but not limited to comparing, classifying, analyzing, and coordinating - minimizing duplication of effort.
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