Quality Assurance Inspector Department Quality Assurance Job Summary Reporting to the Quality Assurance Manager, the Quality Inspector is responsible for providing Quality Assurance input during the development and production of sterile and non-sterile medical supplies and devices. Essential Job Functions Issue batch record and work instructions to manufacturing personnel in accordance with production schedule Perform line inspection prior to production runs; review/approve line clearance documentation Perform inspection and release of product labeling prior to production, perform label reconciliation and final record review at completion of production runs Perform in-process inspection of product during production runs; final inspection of product at completion of production runs Work with suppliers to improve quality and assist QA Manager with supplier qualifications Train employees and contractors on company policies; production procedures and forms; ISO/GMP guidelines/; and the use of new equipment, as appropriate Participate in Internal and External quality audits as directed by the Quality Assurance Manager Assist in the development of procedures for the test and inspection of articles Perform incoming inspection and release of medical devices, device materials, components and subassemblies Performs root cause analysis and completes investigation write-ups for quality related issues Responsible for assisting in maintaining supplier files in accordance with established procedures Responsible for writing and/or assisting in the writing of test and inspection SOPs Responsible for assisting in complaint investigations as related to product quality Responsible for assisting in compiling and reporting on Vendor performance statistics Other duties as assigned Qualifications Undergraduate diploma and minimum two years related experience and/or training; or equivalent combination of education and experience 3+ years in a Quality Control or Quality Assurance position with a medical device manufacturer or related field Proficiency in the use of PC and programs, particularly Excel, Word, Visio, Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals Ability to write routine reports and correspondence Knowledge of testing equipment, statistical methods, control plans Strong work ethic and understanding of basic Quality systems Able to work well independently A strong and dedicated understanding of customer and company needs and basic requisites Ability to speak effectively before groups of customers or employees of organization Ability to maintain records, and prepare reports and correspondence related to the work Ability to conduct investigative interviews Knowledge of federal and departmental quality control policies Knowledge of interviewing techniques and methods for obtaining and communicating information Ability to function as a facilitator in a group setting Competencies Demonstrates ownership and accountability; Demonstrates the ability to plan, execute, control and deliver communicate effectively both written and verbal lead and influence others effectively Physical Requirements Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping, reaching, lifting, carrying, bending/stooping, kneeling/crawling, climbing, balancing, pushing/pulling, vision requirements – close vision. Mental Requirements This position requires the ability to maintain an appropriate work pace, comprehend and follow instructions, exercise logic and reasoning, organize and prioritize, read, compose written communication, communicate verbally, problem solve, count and compute, and multi-task/re-direct. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations. Other Requirements The employee must be trained on all the documents, procedures, software applications and topics listed in the Training Matrix. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the supervisor. Work Environment The noise level in the work environment is usually quiet to moderate. This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.