Quality Engineer

Übersicht

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.

Qualifications

• 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