Development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, use data analysis to better understand quality reporting measures and improve processes.
Essential Job Function
- Assist in providing guidance on product and process validations, including sterilization validation/revalidation, Biocompatibility.
- Updating and/or creating Risk Management documents as per ISO 14971 for new products or product design changes.
- Represent Quality Assurance on Design Control project teams for new or revised products.
- Investigate product or production issues and develop the associated corrective action(s)
- Help oversee and maintain the Calibration and Preventive Maintenance Systems
- Provide competence in Supplier Evaluations/Development/ and Monitoring
- Help Support the maintenance of a quality system in compliance and the applicable regulatory standards/requirements for medical devices.
- Help provide support for Regulatory Submissions and Audits as applicable.
- Assist in Providing Training and Direction for Quality Inspectors and Technicians
- Perform problem identification, resolution, loss reporting and continuous improvement.
- Design and implement methods for process control, process improvement, testing and inspection.
- Develop, execute, and analyze quality reporting measures.
- Participate in internal and external quality audits.
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
- 4+ years' of industry experience
- Strong knowledge of quality tools used in the industry
- Analytical and quantitative approach to problem solving