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Descripción y detalle de las actividades
Lead and monitor compliance with the quality system, FDA regulations and ISO 13485; supervises the CAPA system of the organization and monitors the process of improvement and quality assurance. RESPONSIBILITIES: -Implements and supports methodologies and systems that improve product quality and QS (Management Review, QSR Training, ISO13485). -Lead pre-audit plan preparation to collect pertinent information to support third party Audits. -Stays current with new Regulation updates -Assist Q.A. Manager in the development, documentation, implementation, and maintenance of quality system procedures, instructions, and records. -Member of the CAPA Review Board, acting as responsible for the oversight of the organization’s CAPA system. -Participates and supports the Welch Allyn Quality Improvement Process as required by senior management. Supports and helps implement the Welch Allyn Quality Principles by actively participating in error prevention and problem solving. -Assures that all documentation files are kept current and comply with all FDA and ISO 13485 requirements. -Maintain Document Control system according to standard operating procedures. -Responsible to coordinate and conduct training to employees in activities related to the Engineering Change process in SAP. -Review, approve and process ECR’s into ECO’s in SAP. -Documentation review process of Quality System Documents. -Actively uses quality skills training and participates in all activities related to improving all products and processes impacted by this position -Manage Resources to complains system, SAP. -Responsible for monitoring, identifying tendencies, investigating and solving problems submitted through customer complaints.
Experiencia y requisitos
Education required: B.S. Degree in Engineering, hardware operation, manufacturing and related. Desirable experience: -Minimum 3-5 years’ experience working in Document Control department in an ISO 13485 regulated environment. -Minimum 2-3 years’ experience working with Enterprise Resource Planning (ERP) systems such as SAP, Agile, Oracle or similar software. -Formal education or training in quality control techniques including quality system auditing, statistical process control, design of experiments, regression analysis, and statistical sampling methods, FDA medical device regulations covered under Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC. -Understanding of essential products, processes, procedures, policies, key customers and suppliers. -Experience in high-volume manufacturing company of medical devices. -Knowledge of ISO, FDA concepts and guidelines. -Interface effectively with all levels of company employees. Works on assignments that are complex in nature where considerable judgment and initiative are required to resolve problems. Accuracy is required in performing all functions of this position.
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