Responsible for executing quality control/assurance inspection, testing and verification of finished products, work in-process, procured materials and components to assess and verify conformance to requirements and production process capabilities. Facilitate continuous improvement of customer satisfaction and operational performance. Provide support to other departments including, but not limited to Production, Shipping, Service, and Purchasing.
Apply, or assure the application of, labeling to finished products as required: Serial number labels, certification (CE) and related
Operate various inspection and test equipment in executing quality control/assurance testing and inspection procedures and operations including, but not limited to:
X-ray imaging equipment
Ultrasound imaging equipment
Film processing equipment
Measuring devices such as micrometers, dial indicators, calipers, etc.
Execute specific Quality Management System Procedures as assigned or required
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Education and Experience: Specialized training beyond high school normally gained through a technical program around 18 months duration. Minimum of 2 years’ experience in a quality control/quality assurance testing and inspection role required. ASQ Certification is preferred.
Skills and Knowledge: Work consists of moderately complicated procedures and tasks that require independent judgments such as ability to set and reset task priorities, evaluate results, and coordinate tasks with others. Errors may result in somewhat serious consequences involving customer relations, or damage to expensive equipment. Occasionally required to work or attend meetings beyond the normal workday. Ability to keep sensitive information about the company, products, technology, customers, coworkers, and others confidential is essential.
Requires use of radiographic equipment and subsequent evaluation of radiographs. Ability to operate and maintain a variety of equipment and computer systems, including faxitron, mammographic and general diagnostic x-ray machines; digital precision measuring devices; ultrasound imaging system; film processors; etc.
Ability to operate personal computer using standard computer applications (word processing, spreadsheets, database applications) as well as statistical analysis applications. Ability to read and interpret engineering drawings and specifications and other technical documents. Ability to effectively use measurement and test tools, devices, and equipment (dial indicators, micrometers, height gauges, surface plates, calipers, densitometers, etc) to assess conformance to technical, physical, and performance requirements.
Strong analytical and reasoning skills, organizational skills and capability to pay attention to and work with details are required. Ability to solve a variety of problems in situations where only a limited amount of standardization exists, such as identifying root causes of product non-conformities and process variability, identifying process variability, and ineffective processes and procedures, methods and/or standards. Knowledge of the medical products industry is helpful. Ability to exercise initiative, judgment, discretion, and decision-making is vital.
Strong oral and written communication skills as well as strong interpersonal skills. Courtesy and tact necessary to effectively work with others in everyday working relationships needed.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made enable individuals with disabilities to perform the essential functions.
Most of day is spent standing. Moderate amount of walking, bending and lifting/lowering or pushing/pulling 20 to 50 pounds. Occasional sitting, climbing, crouching. Frequent use of computer and terminal. Frequent use of electrical equipment. Moderate exposure to cold, heat, heights, skin irritants, lung irritants, loud noises, and sharp tools/instruments. Risk from these exposures can be minimized by following company and OSHA safety standards, policies, procedures, and practices.