· Conduct N95 mask sampling plan collection from the production line(s) and operate laboratory test equipment (ATI, TSI and other instruments) in the Quality Lab.
· Employee is expected to follow all safety regulations & wear PPE as required
· Follow established procedures for the inspection, testing and acceptance of components/materials per Approved Supplier List (ASL) used in the manufacture of medical devices.
· Perform review of Device History Records (DHR) and other documentation for release of finished goods.
· Asses nonconforming materials and determine Root Cause Analysis & appropriate disposition.
· Assist in writing, reviewing and updating Quality documents.
· Monitor critical equipment and instrumentation to ensure proper operation and calibration.
· Assist with Developing and implementing Safety systems and SOP’s.
· Cooperates and supports all department supervisors and managers
· Reports to the GM of Operations/Director of Quality
Education and Experience:
· High School, Trade School or equivalent Work Training/Experience
· 4+ years Quality Control Management in a production/manufacturing environment
· Familiar with basic measuring and QA/QC tools & methods
· Knowledge of IQ/OQ/PQ protocols and Continuous Improvement techniques
· 2+ years QC experience in Receiving Inspection is preferred
· Familiarity with ISO9001 QMS essential and NIOSH knowledge a plus
· Willingness to perform/assist in routine maintenance and small repairs
Good Mechanical and Electrical skills are a plus
· Strong attention to details and follows Processes and Procedures
· Excellent verbal and written communication skills in English. Spanish is a plus
· Familiar with basic hand tools, power tools, measuring tools, etc.
· Good math and problem solving skills are essential
· Strong communication skills both verbal and written
· Mechanical aptitude required
· Previous experience in automated production machine operation
· Ability to read and follow instructions & machine blueprints/drawings
· Working knowledge of measurement instruments
· Microsoft Office software skills required
· Authorized to work in U.S. with ability to pass a D.O.D. background check
· Must have valid Driver’s License& Reliable Transportation
· Must be able to pass background check and drug screen
· Highly Motivated Self Starter with excellent work attendance
· Must be a quick learner and able to react quickly and in a fast-paced environment
· Excellent Team Leader and Motivator
· Customer Service/Quality Driven
· Team player and good on time work performance
· Ability to stand and reach with hands and arms to operate and maintain equipment
· Ability to walk sit, climb or balance; stoop, kneel, crouch, or crawl
· Ability to regularly lift and/or move up to 25 pounds