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Director, Quality Assurance And Management Rep
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- We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well such as Regulatory Affairs); must be a self-starter, team builder, and excellent in communication.
- Coordinates the planning, promotion and organization of quality, regulatory and reliability engineering activities, including Design/Development/NPI, DHF/DMR/DHR documentation, supplier qualification, manufacturing, and distribution control.
- Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.
- Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
- Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
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