Job Summary Under the direct supervision of the Quality Supervisor, this position will ensure our parts/products meet applicable quality standards. You will perform in-process inspections to ensure parts/products meet company & ISO:13485 standards. Summary of Essential Job Functions and Responsibilities Perform quality checks on in-process goods. Setup and calibrate testing equipment Record and report quality data Analyze data to identify areas for improvement within the quality system Recommend and monitor corrective and preventive actions Support internal & external audits Assist with audit findings and appropriate corrective actions Ensure accuracy of data recordings (re: job travelers, set-up sheets, quality sheets, etc.) Responsible for maintaining product return & customer complaint records Maintain calibration records via Unipoint software Administrator of NCR’s (non-conformance report), MRB (material review board), and CAPA’s (corrective & preventive actions) via Unipoint Assist with validation activities for processes, equipment, and materials Minimum Requirements High school diploma; or equivalent preferred A minimum of 2 years related experience in a fast-paced manufacturing environment Previous ISO:13485 or ISO:9001 experience preferred Skills and Abilities Required Strong communication skills, both verbally and written Ability to collect and analyze data Good decision-making and problem-solving skills Good organizational, planning, and multi-tasking skills Proficiency with computer programs such as Microsoft Word, Excel, Unipoint, Jobboss Ability to read and decipher blueprints and display a strong attention to detail Ability to work independently and in team situations Ability to lift 20 pounds regularly and up to 40 pounds Must be able to reach, twist, bend, squat, push, pull and climb continuously as needed Work Environment Occasionally exposed to seasonal temperature extremes (heat, cold, wet, and/or humid) Noise level is usually moderate (hearing protection available) #J-18808-Ljbffr