Quality Assurance Specialist Hospital
2 weeks ago
We are seeking a highly skilled Quality Control Engineer to join our team at Devdort. As a Quality Control Engineer, you will play a vital role in ensuring that all medical equipment systems and processes meet regulatory and quality standards.
Key Responsibilities- Develop and implement quality control processes and procedures for medical equipment and systems
- Conduct quality audits and inspections to identify nonconformities and areas for improvement
- Provide technical expertise in evaluating the performance and reliability of medical devices
- Collaborate with cross-functional teams to address quality issues and implement corrective actions
- Analyze data and generate quality reports to track and communicate performance metrics
- Ensure adherence to regulatory standards and compliance with healthcare quality regulations
- Participate in the evaluation and selection of medical products and vendors
- Train and educate staff on quality control processes and best practices
- Conduct risk assessments and contribute to risk management activities
- Drive continuous improvement initiatives to enhance overall quality and efficiency
- Support the development and maintenance of quality management documentation
- Investigate customer complaints and implement preventive measures
- Stay updated on industry trends, best practices, and regulatory changes
- Participate in internal and external quality audits and regulatory inspections
- Contribute to the development and maintenance of quality control-related SOPs
- Bachelor's degree in biomedical engineering, quality management, or a related field
- Proven experience in quality control or assurance within a healthcare or hospital setting
- Knowledge of medical device regulations and quality standards (e.g. FDA, ISO, MDR)
- Strong analytical and problem-solving skills with attention to detail
- Understanding of statistical process control and quality improvement methodologies
- Excellent communication and interpersonal skills
- Ability to work effectively in a multidisciplinary team environment
- Certification in quality management (e.g. CQM, CQE) is a plus
- Familiarity with risk management principles and tools
- Proficiency in using quality management software and tools
- Knowledge of lean principles and continuous improvement techniques
- Understanding of medical terminology and healthcare processes
- Ability to prioritize and manage multiple tasks efficiently
- Adherence to ethical and professional standards in the healthcare industry
- Willingness to stay updated on regulatory changes and industry advancements
continuous improvement, risk, medical device regulations knowledge, risk management principles, multidisciplinary team work, statistical process control, technical expertise, customer complaints investigation, medical terminology knowledge, quality management documentation, communication skills, management, lean principles, continuous improvement initiatives, quality control, adherence, internal and external quality audits, interpersonal skills, SOPs development and maintenance, analytical skills, regulations, regulatory standards compliance, maintenance, ethical standards adherence, quality audits, healthcare, risk assessments, quality control processes
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