•Provide quality representation to design control, design verification and validation, design transfer, process validation, risk management and specification development on assigned product development teams to assure compliance with global regulations, including CE, FDA Quality System Regulation and ISO 13485.
•Participate on teams to ensure robust application of appropriate design and manufacturing controls.
•Work with Senior Engineers and leadership to ensure quality and completeness of project design history files, risk management files, validation packages and change orders.
•Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes and CAPA investigations.
•Participate in technical discussions and risk-based decision making.
•Under supervision, review verification and validation reports and identify gaps for compliance with global regulations.
•Develop and execute strategies to close gaps in an efficient, technical and compliant manner.
•Identify opportunities and recommend improvements to design and development process; continuous improvement.
•Bachelor's degree in an Engineering or Science discipline.
•2-5 years of experience working in a Quality Assurance role in a regulated environment.
•Experience working with implantable devices preferred.
•Experience applying quality regulations and standards preferred (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.).
•Experience with CAPA and failure investigation tools and techniques.
•Practical experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.).
•Knowledge of ERP Systems (SAP preferred) and intermediate Microsoft Office; intermediate/ advanced level Microsoft Excel skills.