The Sr. Quality Engineer must have excellent problem solving and presentation skills, learns a new environment quickly. The Sr. Quality Engineer must have the charisma and credibility to communicate and influence change at all levels within the organization. This role will identify, communicate and implement the key priorities to the organization with little guidance or direction and exercising judgment to determine sense of urgency for priority. The Sr. Quality Engineer will continuously demonstrate strong Envista values. This role will foster cross-functional problem solving and cooperation.
- Bachelor’s Degree in Engineering or related fields required.
- 5+ years of experience in progressive Quality Assurance role, exposure to FDA regulations / ISO 13485 requirements is required.
- Experience with statistical software packages (E.g. Minitab), as well as Microsoft Office tools.
- Sense of urgency : Action-oriented and able to recognize problems and opportunities. Communication : Effectively communicate to all levels within the organization and influence change outside of the local span of control.
- Customer Focus: A drive to discover and meet the needs of customers (either internal or external) Results Oriented: A drive to achieve results and goals in the short and long term. Adaptable to Change: The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically make decisions in a timely fashion, especially when there is not a clear path.
- Analytical : Conducts comprehensive review of quality issues and complaints.
- Leadership : Supervises large team of associates, with commitment to identifying and developing talent. Ability to influence others : Must be able to inform, convince, and persuade others to action on key initiatives.
- Experience with Root Cause analysis, Statistical Techniques, Lean Manufacturing, and Six Sigma preferred.
- Experience and working knowledge of electrical medical device manufacturing preferred.
- Experience with SAP helpful, but not required. Experience with MDSAP requirements and EU MDD/MDR regulations is preferred.