Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations.Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance with regulations and standards.Qualifications and Experience:Previous industry experience desired.Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.Understanding of US and International Medical Device Regulations.Familiarity with ISO 13485, GDP, GMP desired.Strong knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics).Must possess strong communication, project management, and influencing skills, with the ability to manage multiple tasks simultaneously.Ability to represent the Quality function within project teams.Strong interpersonal, written, and oral communication and negotiation skills.Strong critical thinking and "outside the box" thinking.Highly developed problem-solving and analytical skills.Ability to work independently and as part of cross-functional teams.Experience working in a compliance risk environment.Computer literacy required.Some travel may be required.
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