We are looking for Quality Engineer for Medical Devices for our client in Franklin Lakes, NJ
Job Title: Quality Engineer for Medical Devices
Job Location: Franklin Lakes, NJ
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
- Accountable for supporting new medical electrical equipment /system development and maintenance through the application of Quality Engineering skills for medical devices.
- Knowledge and experience with medical electrical systems and handle and projects and tasks, from project inception through product launch and maintenance
- Play an active role in the processes to ensure products meets quality /regulatory standards consistent with both Corporate and unit policies, will meeting all design control and other regulatory requirements.
- Knowledge of Electrical systems, products, components, applications, component‘s capabilities, electrical testing methods, testing finished products and system capabilities.
- Provide coordination and guidance to cross functional teams to ensure product quality objectives are met.
- Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results.
- Demonstrate functional knowledge and expertise in product development, verifications, validations, reliability, human factors, regulatory requirements, international standards and risk management.
- Track record of root cause determination and effective corrective / preventive action implementation.
- Provides training for product development teams and continuous improvement team on best practices.
- Conducts audits as member of a quality system audit team
- Writes and leads risk management activities including risk management reports, hazard analysis and failure analysis