Experience, self-sufficient representative that primarily works with a cross-functional team, such as Manufacturing, R&D, Regulatory, Quality Engineering, etc. In this position, your primary mission is to play a pivotal role in upholding the efficiency of the Quality Assurance department and ensuring unwavering compliance with our Quality Management System. This encompasses strict adherence to a comprehensive set of regulatory standards, including FDA GMP, ISO 13485, and MDSAP, among others. Works independently to support efficient operations of the Quality Assurance department and compliance of the Quality Management system to ensure the quality of products and processes. This role is central to safeguarding the quality of our products and processes. By adhering to these standards, you help to minimize the risk of defects and enhance the quality and safety of our products. Your dedication is essential to ensure that we not only meet but consistently exceed the quality expectations of our customers.

Beyond quality, your efforts contribute to the organization's compliance with an array of other pertinent regulatory requirements that pertain to our industry and the markets we serve. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access.

What you will do:

• Escalate issues to QA and/or Engineering Management if quality issues arise. Resolve quality related issues between the QA department and other departments.
• Coordinate with engineers, technicians, and production or other department heads to ensure quality standards are maintained.
• Ensure containment (identification, segregation, and reconciliation) of non-conforming product has been performed.
• Participate in cross-functional team to investigate quality issues/problems, perform risk assessments, historical record review and disposition and correction/corrective action strategy for non-conformances.
• Monitor and trend quality data to identify potential quality issues.  Provide trended quality data to Management.
• Interpret and utilize Risk Management Files (Failure Modes and Effects Analysis).
• Ensure compliance to the Quality Management System and may own corrective actions (CAPA).
• Apply statistical methods to define sampling plans for Verification of Effectiveness.
• Evaluate required changes to electronic Quality Management systems for continued compliance to external standards and regulations.  Assist in the implementation of new Quality modules in the electronic Quality Management system.
• Support audit activities including supporting external audits and addressing audit findings

What you need:

• Computer skills including Word, Excel and Internet Experience.
• Bachelor’s degree in Engineering or related technical field.
• Minimum 5 years of Quality Engineering experience
• English proficiency both written and verbal
• General knowledge of 21 CFR 820, ISO 13485 and MDSAP