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 to regulation and standards.
Experience in 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 as well as have the ability to manage multiple tasks simultaneously.
Ability to represent Quality function with project teams.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and ""outside the box"" thinking.
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to work independently and as part of cross-functional teams.
Experience in working in a compliance risk situation.
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