Administrative, Codes and Standards, Legal, Operations
4 Year Degree
The primary responsibility of this position is to support all aspects of the Quality Management System, with a primary focus on design control, auditing, manufacturing controls, nonconforming materials, supplier evaluations/corrective action requests and training. This position will also support other areas of the Quality Assurance department and additional tasks determined by management.
ESSENTIAL DUTIES & RESPONSIBILITIES
Assist in the implementation of corporate policies and procedures related to quality, project management, process development and ISO 13485/FDA QSR compliance
Support design control process in the planning, design, preparation, execution, reporting, and analysis of design verification testing; and process validations to approve equipment, processes, and software
Verify quality of manufacturing processes; perform environmental monitoring and periodic ESD verification testing; ensure equipment is calibrated
Perform new supplier evaluations, monitor existing suppliers, issue corrective action requests and perform periodic re-evaluations
Oversee nonconforming materials and participate in Material Review Board evaluations; assign disposition of nonconforming materials
Ensure required training is identified, completed and documented
Assist in the completion of corrective/preventive actions (CAPAs); perform root cause analysis to determine the true cause of nonconformities
Perform audits; participate in FDA inspections and ISO 13485 audits
Regenesis Biomedical is an Arizona based medical device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain, restore health, and improve quality of life. As a company, we value dedication, innovation, integrity, respect, excellence, compassion and teamwork.
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