Be the engineering force behind quality and continuous improvement! Cicor Solon, OH is seeking a Quality Engineer to provide quality assurance support to the product development team, resolve defects and any other issues to ensure that products meet customer specifications.
Quality Engineer
Key Responsibilities
Understanding of ISO 13485:2016 requirements, (e.g. FMEA, CAPA, Root Cause Corrective Action and Customer Feedback).
Create and maintain quality Metrics when assigned Execute design controls and analyze design inputs.
Purchasing and Supplier controls
Implementing receiving inspection criteria.
Develop and implement Data Analysis metrics.
Leads investigations related to quality problems.
Ability to define and manage risk-management plan, risk assessment and risk-control tools.
Facilitate or independently lead non-conforming product investigations, including corrective/preventive actions and product remedial actions.
Responsible for systems assurance including documentation, testing and inspection, and product and process development.
Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.
Identify and lead product and systems continuous improvement initiatives.
Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Manufacturing, Supply Chain, Customer Service, Sales, and other functions as necessary.
Able to influence decisions in a cross-functional team setting.